Roux-en-y Anastomosis SiteAMULETNCT06543316
Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
A study testing Low Thermal Plasma (LTP) Treatment in people with Roux-en-y Anastomosis Site and Marginal Ulcer, run by Christopher C. Thompson, MD, MSc at 1 site in United States.
Trial summary
The objective of the study is to investigate the treatment of marginal ulcers with Low Thermal plasma in an endoscopic setting. By a treatment of the ulcerated areas with argon plasma with low power settings (~ 1 W) we hypothesize that the size of the ulcers will shrink, and the healing is accelerated compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Roux-en-y Anastomosis Site, Marginal Ulcer, Marginal Ulcer (Peptic) or Erosion
- What is being tested?
- Low Thermal Plasma (LTP) Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18 years and above, inclusive of both males and females.
- Patients with a history of Roux-en-Y gastric bypass (RYGB) presenting symptoms indicative of marginal ulcers (MUs) such as abdominal pain, nausea, vomiting, gastrointestinal bleeding, or dysphagia.
- Subjects must be scheduled for an EGD for the evaluation of these symptoms.
- Marginal ulcers confirmed during the initial EGD.
- Willingness to adhere to the SOC treatment, which includes PPIs.
- Subjects able to tolerate repeated endoscopic procedures.
- Capacity for providing informed consent and understanding of study requirements.
- Willingness and ability to attend required follow-up assessments at 4 weeks (+/- 1 week) and 8 weeks (+/- 2 weeks).
Who cannot join
- Inability to provide informed consent.
- Unwillingness to undergo repeated endoscopies.
- Inability or unwillingness to comply with the SOC.
- Current use of systemic antibiotics.
- Any condition deemed by the investigator to compromise the safety of undergoing an endoscopic procedure.
- Pregnancy, lactation, or absence of reliable contraception in women of childbearing potential.
- Current enrollment in another investigational trial with potential to interfere with this study's endpoint analyses.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Michele B. Ryan, MS, 6175258266, mryan@bwh.harvard.edu
Christopher C. Thompson, MD, MSc
About this study
Official title: Accelerated Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
The objective of the study is to investigate the treatment of marginal ulcers with Low Thermal plasma in an endoscopic setting. By a treatment of the ulcerated areas with argon plasma with low power settings (~ 1 W) we hypothesize that the size of the ulcers will shrink, and the healing is accelerated compared to standard of care alone. Patients will benefit from this minimally invasive approach compared to a much more invasive surgical approach that comes with higher risks and hospital stay length time. From a societal and scientific perspective, this study aims to extend the well-documented clinical benefits of plasma technology - from external wound healing to internal ulcer treatment - within an endoscopic framework. The success of this study could pave the way for broader applications of LTP in the treatment of other endoscopically accessible conditions such as peptic ulcers, duodenal ulcers and esophageal ulcers. This advancement has the potential not only to improve patient outcomes through less invasive methods, but also to position LTP as a cornerstone in the future of gastroenterological wound management strategies.
Read the detailed description
Gastric bypass surgery, specifically Roux-en-Y gastric bypass (RYGB), is the second most common bariatric procedure performed worldwide (29.3%) after sleeve gastrectomy (55.4%). Despite its success in reducing obesity-related conditions, RYGB is associated with the development of marginal ulcers (MUs)-internal wounds at the gastrojejunal anastomosis prone to poor healing. The incidence of MUs in patients post-RYGB ranges widely, reported at 0.6% to 25% in the U.S., with some estimates as high as 34% worldwide due to asymptomatic cases that go undetected unless investigated endoscopically. These ulcers can become chronic and persisting over time, significantly complicating post-surgical outcomes and increasing the risk of severe complications like perforation, which necessitates urgent surgical intervention in approximately 1-2% of cases.
The current standard of care for MUs involves prolonged use of proton pump inhibitors (PPIs), which reduce gastric acidity to promote ulcer healing. However, this approach addresses only one aspect of MU pathophysiology and is limited by several shortcomings. It is often insufficient in preventing recurrence and carries risks of significant side effects, including increased risk of infection, electrolyte imbalances, and potential kidney disease, particularly with long-term use. Standard therapy is 8 weeks high-dose treatment, and a lifelong PPI therapy is considered if success is seen with medical management. For those not responding to 8 weeks of therapy, most advocate for continued PPI treatment with serial endoscopic evaluation, even up to 2 years out from initial diagnosis. Given these challenges, there is an evident need for alternative treatments that can more effectively target the underlying causes of MUs and reduce the reliance on PPIs.
Low-thermal or low-temperature plasma (LTP) represents a significant advance in accelerated wound healing technologies. As the fourth state of matter, physical plasma is used in the field of plasma medicine to treat a variety of medical conditions at atmospheric pressure and temperatures close to body temperature (typically between 20°C and 50°C). Over the past 10 to 15 years, wound healing has been a primary clinical application for LTP, with extensive use demonstrating its clinical efficacy in the treatment of chronic and poorly healing wounds.
The mechanisms by which LTP facilitates wound healing include oxygenation of tissues, activation of growth factors, improvement of microcirculation, reduction of bacterial load in wounds, and devitalization of senescent cells. These effects are primarily achieved by the ionization of argon gas and the generation of reactive oxygen and nitrogen species (RONS) in the gas phase. Clinically, LTP has been applied to a variety of wound types, including pressure ulcers, chronic wounds, and acute wounds, and has demonstrated effectiveness across a range of wound sizes and stages. LTP treatments are particularly noted for their ability to transform chronic wounds into actively healing wounds, thereby altering the physiological state of the wound.
Several studies have rigorously evaluated the safety profile of LTP and confirmed that it does not pose mutagenic or carcinogenic risks. Long-term evaluations have shown no evidence of tumor formation or abnormal tissue architecture in gas plasma-treated animal models, even after extended periods corresponding to 60 human-equivalent years. Patient follow-up studies using advanced imaging techniques have further confirmed the absence of abnormal healing responses, supporting the absence of adverse long-term effects.
Currently, the most common low-thermal plasma sources used to treat external wounds are PlasmaJets and Dielectric Barrier Discharge (DBD) plasma sources. However, the physical dimensions of these devices limit their use in endoscopic applications. This has limited the availability of LTP for the treatment of internal wounds and ulcers.
Argon plasma coagulation (APC) is a technology that has been used in endoscopy for more than three decades. It has demonstrated clinical safety and efficacy in many areas, including bleeding management (e.g., bleeding ulcers), ablation of cancerous tissue, and precise treatment in sensitive areas. It is primarily used in endoscopic procedures with flexible probes, but also in laparoscopic and open surgery settings. The flexible probes are available in various diameters, 1.5 mm, 2.3 mm and 3.2 mm.
APC works by ionizing argon gas with a high-frequency alternating current passed through an electrode. This ionized gas forms a physical plasma that is applied to tissue. Depending on the mode and effect setting, the plasma can be adjusted in power from as low as 1 W to as high as 120 W. At higher power settings (5 W and above), the plasma exhibits a more pronounced thermal effect due to increased current flow through the tissue, facilitating effective coagulation. Conversely, at lower settings below 5 W, a low-thermal plasma effect is achieved, minimizing tissue coagulation through dynamic application and avoiding prolonged exposure to a single spot. As with PlasmaJets and Dielectric Barrier Discharge (DBD) plasma sources, the effectiveness of low-thermal argon plasma is primarily due to the high energy and voltage that generate reactive oxygen and nitrogen species (RONS).
- Conditions
- Roux-en-y Anastomosis Site, Marginal Ulcer, Marginal Ulcer (Peptic) or Erosion, Ulcer, Ulcer, Gastric, Ulcer Gastrointestinal
- Being tested
- Low Thermal Plasma (LTP) Treatment, Standard of Care Ulcer Treatment (typically PPI Administration)
- Keywords
- Argon Plasma Coagulation, APC, Low-Thermal Argon Plasma Endoscopic Treatment, Endoscopy, RYGB, Roux-en-Y Gastric Bypass, Ulcer Healing
- Medical subject headings
- Peptic Ulcer, Ulcer, Stomach Ulcer, Abdominal Pain, Nausea, Vomiting, Gastrointestinal Hemorrhage, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Thermal Plasma (LTP) TreatmentProcedure or surgery
Also called LTP
For patients randomized to the LTP group, the first LTP treatment will be administered during the initial esophagogastroduodenoscopy (EGD) using a single-use 2.3 mm filtered argon plasma coagulation (FiAPC probe). The argon plasma will be applied at low power settings (~1 W) to the ulcerated areas using pulsed APC effect 0.1.
Standard of Care Ulcer Treatment (typically PPI Administration)Other
Also called PPI
Standard of care for treatment of ulcers is administration of a proton pump inhibitor (PPI). For patients in the SOC group whose ulcers have not healed completely by the second follow-up at 8 weeks, crossover to LTP treatment will be offered. This treatment will follow the same procedure as the initial LTP treatment.
| Study group | Role | What they receive |
|---|---|---|
| Low Thermal Plasma (LTP) | Active comparator | Patients randomized to this group will receive LTP treatment of the ulcer in addition to SOC (PPI administration). Receives: Procedure: Low Thermal Plasma (LTP) Treatment; Other: Standard of Care Ulcer Treatment (typically PPI Administration) |
| Standard of Care (SOC) PPI Administration | Active comparator | Patients randomized to this group will receive only the SOC treatment (PPI administration). Receives: Other: Standard of Care Ulcer Treatment (typically PPI Administration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer Healing Success Rate from baseline endoscopy
Complete healing or significant reduction in ulcer size, determined by endoscopic evaluation at the first follow-up (4 weeks +/- 1 week) and at the end of the second follow-up period (8 weeks +/- 2 weeks).
Measured: Baseline, 4 weeks, 8 Weeks
Secondary outcomes (5)
Comparison of Time to Ulcer Healing between LTP and SOC groups
To measure the time in days from initial treatment to complete ulcer healing in both treatment phases, accounting for the initial ulcer size.
Measured: Baseline, 4 weeks, 8 weeks
Improvement of Tissue Oxygenation at Ulcer Site in LTP treatment group
To measure the change of the tissue oxygenation in the ulcerated area directly after the LTP treatment and at the follow-up visits. Level of tissue oxygenation will be compared to a baseline measurement before the initial LTP treatment. Level of tissue oxygenation measured by light absorption with an image sensor (ELUXEO Vision System, Fujifilm).
Measured: Baseline, 4 weeks, 8 weeks
Presence of Procedure-Related Adverse Events
To evaluate the safety profile of LTP by recording the presence of adverse events such as bleeding, perforation, and infection in both initial and crossover phases from during the procedure up to 8 weeks post-procedure.
Measured: Baseline, up to 8 weeks
Clinical Improvement of Gastrointestinal Symptoms
Change in Gastrointestinal Symptoms from Baseline Using the gastrointestinal symptom rating scale (GSRS). This has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Measured: Baseline, 8 Weeks
Change in quality of life score from baseline using the 12 item Short Form Survey (SF-12)
Comparison of quality of life scores from baseline to 4 weeks post-treatment using the SF-12 scoring system. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less has been recommended as a cut-off to determine a physical condition in the Physical Health Composite Score (PCS) section; while a score of 42 or less may be indicative of 'clinical depression' Mental Health Composite Score (MCS) section.
Measured: Baseline, 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start4 Mar 2025
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Roux-en-y Anastomosis SiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, two-arm, crossover clinical study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christopher C. Thompson, MD, MSc
- Sponsor type
- University, hospital or other
- Collaborators
- Erbe USA Incorporated
- Responsible party
- Sponsor-investigator, Christopher C. Thompson, MD, MSc, Brigham and Women's Hospital
- Investigators
- Christopher C. Thompson, MD, MSc, Principal investigator, Brigham and Womens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543316
- Sponsor's protocol ID
- 2024P002124
- Acronym
- AMULET
- Status last verified
- Jun 2026
- First submitted
- 2 Aug 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) will be shared on a case by case basis with an Institutional data transfer agreement in place.
Publications
Angrisani L, Santonicola A, Iovino P, Ramos A, Shikora S, Kow L. Bariatric Surgery Survey 2018: Similarities and Disparities Among the 5 IFSO Chapters. Obes Surg. 2021 May;31(5):1937-1948. doi: 10.1007/s11695-020-05207-7. Epub 2021 Jan 12.
PubMed 33432483Sapala JA, Wood MH, Sapala MA, Flake TM Jr. Marginal ulcer after gastric bypass: a prospective 3-year study of 173 patients. Obes Surg. 1998 Oct;8(5):505-16. doi: 10.1381/096089298765554061.
PubMed 9819081Coblijn UK, Goucham AB, Lagarde SM, Kuiken SD, van Wagensveld BA. Development of ulcer disease after Roux-en-Y gastric bypass, incidence, risk factors, and patient presentation: a systematic review. Obes Surg. 2014 Feb;24(2):299-309. doi: 10.1007/s11695-013-1118-5.
PubMed 24234733Steinemann DC, Bueter M, Schiesser M, Amygdalos I, Clavien PA, Nocito A. Management of anastomotic ulcers after Roux-en-Y gastric bypass: results of an international survey. Obes Surg. 2014 May;24(5):741-6. doi: 10.1007/s11695-013-1152-3.
PubMed 24347350Choi J, Polistena C. Management of Marginal Ulceration. In: Camacho D, Zundel N, eds. Complications in Bariatric Surgery. Cham: Springer International Publishing; Imprint: Springer; 2018: 45-58
Carr WR, Mahawar KK, Balupuri S, Small PK. An evidence-based algorithm for the management of marginal ulcers following Roux-en-Y gastric bypass. Obes Surg. 2014 Sep;24(9):1520-7. doi: 10.1007/s11695-014-1293-z.
PubMed 24851857Adamovich I, Agarwal S, Ahedo E et al. The 2022 Plasma Roadmap: low temperature plasma science and technology. Plasma Sources Sci. Technol. 2022; 55: 373001
Chuangsuwanich A, Assadamongkol T, Boonyawan D. The Healing Effect of Low-Temperature Atmospheric-Pressure Plasma in Pressure Ulcer: A Randomized Controlled Trial. Int J Low Extrem Wounds. 2016 Dec;15(4):313-319. doi: 10.1177/1534734616665046. Epub 2016 Sep 20.
PubMed 27581113Mirpour S, Fathollah S, Mansouri P, Larijani B, Ghoranneviss M, Mohajeri Tehrani M, Amini MR. Cold atmospheric plasma as an effective method to treat diabetic foot ulcers: A randomized clinical trial. Sci Rep. 2020 Jun 26;10(1):10440. doi: 10.1038/s41598-020-67232-x.
PubMed 32591594Hartwig S, Preissner S, Voss JO, Hertel M, Doll C, Waluga R, Raguse JD. The feasibility of cold atmospheric plasma in the treatment of complicated wounds in cranio-maxillo-facial surgery. J Craniomaxillofac Surg. 2017 Oct;45(10):1724-1730. doi: 10.1016/j.jcms.2017.07.008. Epub 2017 Jul 27.
PubMed 28843407Isbary G, Morfill G, Schmidt HU, Georgi M, Ramrath K, Heinlin J, Karrer S, Landthaler M, Shimizu T, Steffes B, Bunk W, Monetti R, Zimmermann JL, Pompl R, Stolz W. A first prospective randomized controlled trial to decrease bacterial load using cold atmospheric argon plasma on chronic wounds in patients. Br J Dermatol. 2010 Jul;163(1):78-82. doi: 10.1111/j.1365-2133.2010.09744.x. Epub 2010 Mar 5.
PubMed 20222930Abu Rached N, Kley S, Storck M, Meyer T, Stucker M. Cold Plasma Therapy in Chronic Wounds-A Multicenter, Randomized Controlled Clinical Trial (Plasma on Chronic Wounds for Epidermal Regeneration Study): Preliminary Results. J Clin Med. 2023 Aug 4;12(15):5121. doi: 10.3390/jcm12155121.
PubMed 37568525Bekeschus S, von Woedtke T, Emmert S, Schmidt A. Medical gas plasma-stimulated wound healing: Evidence and mechanisms. Redox Biol. 2021 Oct;46:102116. doi: 10.1016/j.redox.2021.102116. Epub 2021 Aug 28.
PubMed 34474394Graves DB. The emerging role of reactive oxygen and nitrogen species in redox biology and some implications for plasma applications to medicine and biology. Plasma Sources Sci. Technol. 2012; 45: 263001
Gao J, Wang L, Xia C, Yang X, Cao Z, Zheng L, Ko R, Shen C, Yang C, Cheng C. Cold atmospheric plasma promotes different types of superficial skin erosion wounds healing. Int Wound J. 2019 Oct;16(5):1103-1111. doi: 10.1111/iwj.13161. Epub 2019 Jun 17.
PubMed 31207094
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
- ClinicalTrials.gov ID
- NCT06543316
- Acronym / sponsor ID
- AMULET / 2024P002124
- Conditions
- Roux-en-y Anastomosis Site, Marginal Ulcer, Marginal Ulcer (Peptic) or Erosion, Ulcer, Ulcer, Gastric, Ulcer Gastrointestinal
- Keywords
- Argon Plasma Coagulation, APC, Low-Thermal Argon Plasma Endoscopic Treatment, Endoscopy, RYGB, Roux-en-Y Gastric Bypass, Ulcer Healing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Christopher C. Thompson, MD, MScUniversity, hospital or other
- Collaborators
- Erbe USA Incorporated
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to investigate the treatment of marginal ulcers with Low Thermal plasma in an endoscopic setting. By a treatment of the ulcerated areas with argon plasma with low power settings (~ 1 W) we hypothesize that the size of the ulcers will shrink, and the healing is accelerated compared to standard of care alone. Patients will benefit from this minimally invasive approach compared to a much more invasive surgical approach that comes with higher risks and hospital stay length time. From a societal and scientific perspective, this study aims to extend the well-documented clinical benefits of plasma technology - from external wound healing to internal ulcer treatment - within an endoscopic framework. The success of this study could pave the way for broader applications of LTP in the treatment of other endoscopically accessible conditions such as peptic ulcers, duodenal ulcers and esophageal ulcers. This advancement has the potential not only to improve patient outcomes through less invasive methods, but also to position LTP as a cornerstone in the future of gastroenterological wound management strategies.
Detailed description
Gastric bypass surgery, specifically Roux-en-Y gastric bypass (RYGB), is the second most common bariatric procedure performed worldwide (29.3%) after sleeve gastrectomy (55.4%). Despite its success in reducing obesity-related conditions, RYGB is associated with the development of marginal ulcers (MUs)-internal wounds at the gastrojejunal anastomosis prone to poor healing. The incidence of MUs in patients post-RYGB ranges widely, reported at 0.6% to 25% in the U.S., with some estimates as high as 34% worldwide due to asymptomatic cases that go undetected unless investigated endoscopically. These ulcers can become chronic and persisting over time, significantly complicating post-surgical outcomes and increasing the risk of severe complications like perforation, which necessitates urgent surgical intervention in approximately 1-2% of cases.
The current standard of care for MUs involves prolonged use of proton pump inhibitors (PPIs), which reduce gastric acidity to promote ulcer healing. However, this approach addresses only one aspect of MU pathophysiology and is limited by several shortcomings. It is often insufficient in preventing recurrence and carries risks of significant side effects, including increased risk of infection, electrolyte imbalances, and potential kidney disease, particularly with long-term use. Standard therapy is 8 weeks high-dose treatment, and a lifelong PPI therapy is considered if success is seen with medical management. For those not responding to 8 weeks of therapy, most advocate for continued PPI treatment with serial endoscopic evaluation, even up to 2 years out from initial diagnosis. Given these challenges, there is an evident need for alternative treatments that can more effectively target the underlying causes of MUs and reduce the reliance on PPIs.
Low-thermal or low-temperature plasma (LTP) represents a significant advance in accelerated wound healing technologies. As the fourth state of matter, physical plasma is used in the field of plasma medicine to treat a variety of medical conditions at atmospheric pressure and temperatures close to body temperature (typically between 20°C and 50°C). Over the past 10 to 15 years, wound healing has been a primary clinical application for LTP, with extensive use demonstrating its clinical efficacy in the treatment of chronic and poorly healing wounds.
The mechanisms by which LTP facilitates wound healing include oxygenation of tissues, activation of growth factors, improvement of microcirculation, reduction of bacterial load in wounds, and devitalization of senescent cells. These effects are primarily achieved by the ionization of argon gas and the generation of reactive oxygen and nitrogen species (RONS) in the gas phase. Clinically, LTP has been applied to a variety of wound types, including pressure ulcers, chronic wounds, and acute wounds, and has demonstrated effectiveness across a range of wound sizes and stages. LTP treatments are particularly noted for their ability to transform chronic wounds into actively healing wounds, thereby altering the physiological state of the wound.
Several studies have rigorously evaluated the safety profile of LTP and confirmed that it does not pose mutagenic or carcinogenic risks. Long-term evaluations have shown no evidence of tumor formation or abnormal tissue architecture in gas plasma-treated animal models, even after extended periods corresponding to 60 human-equivalent years. Patient follow-up studies using advanced imaging techniques have further confirmed the absence of abnormal healing responses, supporting the absence of adverse long-term effects.
Currently, the most common low-thermal plasma sources used to treat external wounds are PlasmaJets and Dielectric Barrier Discharge (DBD) plasma sources. However, the physical dimensions of these devices limit their use in endoscopic applications. This has limited the availability of LTP for the treatment of internal wounds and ulcers.
Argon plasma coagulation (APC) is a technology that has been used in endoscopy for more than three decades. It has demonstrated clinical safety and efficacy in many areas, including bleeding management (e.g., bleeding ulcers), ablation of cancerous tissue, and precise treatment in sensitive areas. It is primarily used in endoscopic procedures with flexible probes, but also in laparoscopic and open surgery settings. The flexible probes are available in various diameters, 1.5 mm, 2.3 mm and 3.2 mm.
APC works by ionizing argon gas with a high-frequency alternating current passed through an electrode. This ionized gas forms a physical plasma that is applied to tissue. Depending on the mode and effect setting, the plasma can be adjusted in power from as low as 1 W to as high as 120 W. At higher power settings (5 W and above), the plasma exhibits a more pronounced thermal effect due to increased current flow through the tissue, facilitating effective coagulation. Conversely, at lower settings below 5 W, a low-thermal plasma effect is achieved, minimizing tissue coagulation through dynamic application and avoiding prolonged exposure to a single spot. As with PlasmaJets and Dielectric Barrier Discharge (DBD) plasma sources, the effectiveness of low-thermal argon plasma is primarily due to the high energy and voltage that generate reactive oxygen and nitrogen species (RONS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, two-arm, crossover clinical study
| Arm | Type | Receives |
|---|---|---|
| Low Thermal Plasma (LTP) | Active comparator | Procedure: Low Thermal Plasma (LTP) Treatment, Other: Standard of Care Ulcer Treatment (typically PPI Administration)Patients randomized to this group will receive LTP treatment of the ulcer in addition to SOC (PPI administration). |
| Standard of Care (SOC) PPI Administration | Active comparator | Other: Standard of Care Ulcer Treatment (typically PPI Administration)Patients randomized to this group will receive only the SOC treatment (PPI administration). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects aged 18 years and above, inclusive of both males and females.
- Patients with a history of Roux-en-Y gastric bypass (RYGB) presenting symptoms indicative of marginal ulcers (MUs) such as abdominal pain, nausea, vomiting, gastrointestinal bleeding, or dysphagia.
- Subjects must be scheduled for an EGD for the evaluation of these symptoms.
- Marginal ulcers confirmed during the initial EGD.
- Willingness to adhere to the SOC treatment, which includes PPIs.
Key exclusion criteria (7 listed)
- Inability to provide informed consent.
- Unwillingness to undergo repeated endoscopies.
- Inability or unwillingness to comply with the SOC.
- Current use of systemic antibiotics.
- Any condition deemed by the investigator to compromise the safety of undergoing an endoscopic procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Thermal Plasma (LTP) TreatmentAlso: LTPFor patients randomized to the LTP group, the first LTP treatment will be administered during the initial esophagogastroduodenoscopy (EGD) using a single-use 2.3 mm filtered argon plasma coagulation (FiAPC probe). The argon plasma will be applied at low power settings (~1 W) to the ulcerated areas using pulsed APC effect 0.1. | Procedure or surgery | Low Thermal Plasma (LTP) |
| Standard of Care Ulcer Treatment (typically PPI Administration)Also: PPIStandard of care for treatment of ulcers is administration of a proton pump inhibitor (PPI). For patients in the SOC group whose ulcers have not healed completely by the second follow-up at 8 weeks, crossover to LTP treatment will be offered. This treatment will follow the same procedure as the initial LTP treatment. | Other | Low Thermal Plasma (LTP), Standard of Care (SOC) PPI Administration |
Primary outcome
Ulcer Healing Success Rate from baseline endoscopy
Time frame: Baseline, 4 weeks, 8 Weeks
Complete healing or significant reduction in ulcer size, determined by endoscopic evaluation at the first follow-up (4 weeks +/- 1 week) and at the end of the second follow-up period (8 weeks +/- 2 weeks).
5 secondary outcomes
Comparison of Time to Ulcer Healing between LTP and SOC groups
Time frame: Baseline, 4 weeks, 8 weeks
Improvement of Tissue Oxygenation at Ulcer Site in LTP treatment group
Time frame: Baseline, 4 weeks, 8 weeks
Presence of Procedure-Related Adverse Events
Time frame: Baseline, up to 8 weeks
Clinical Improvement of Gastrointestinal Symptoms
Time frame: Baseline, 8 Weeks
Change in quality of life score from baseline using the 12 item Short Form Survey (SF-12)
Time frame: Baseline, 8 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 33432483Angrisani L, Santonicola A, Iovino P, Ramos A, Shikora S, Kow L. Bariatric Surgery Survey 2018: Similarities and Disparities Among the 5 IFSO Chapters. Obes Surg. 2021 May;31(5):1937-1948. doi: 10.1007/s11695-020-05207-7. Epub 2021 Jan 12.
- Background: PubMed 9819081Sapala JA, Wood MH, Sapala MA, Flake TM Jr. Marginal ulcer after gastric bypass: a prospective 3-year study of 173 patients. Obes Surg. 1998 Oct;8(5):505-16. doi: 10.1381/096089298765554061.
- Background: PubMed 24234733Coblijn UK, Goucham AB, Lagarde SM, Kuiken SD, van Wagensveld BA. Development of ulcer disease after Roux-en-Y gastric bypass, incidence, risk factors, and patient presentation: a systematic review. Obes Surg. 2014 Feb;24(2):299-309. doi: 10.1007/s11695-013-1118-5.
- Background: PubMed 24347350Steinemann DC, Bueter M, Schiesser M, Amygdalos I, Clavien PA, Nocito A. Management of anastomotic ulcers after Roux-en-Y gastric bypass: results of an international survey. Obes Surg. 2014 May;24(5):741-6. doi: 10.1007/s11695-013-1152-3.
- BackgroundChoi J, Polistena C. Management of Marginal Ulceration. In: Camacho D, Zundel N, eds. Complications in Bariatric Surgery. Cham: Springer International Publishing; Imprint: Springer; 2018: 45-58
- Background: PubMed 24851857Carr WR, Mahawar KK, Balupuri S, Small PK. An evidence-based algorithm for the management of marginal ulcers following Roux-en-Y gastric bypass. Obes Surg. 2014 Sep;24(9):1520-7. doi: 10.1007/s11695-014-1293-z.
- BackgroundAdamovich I, Agarwal S, Ahedo E et al. The 2022 Plasma Roadmap: low temperature plasma science and technology. Plasma Sources Sci. Technol. 2022; 55: 373001
- Background: PubMed 27581113Chuangsuwanich A, Assadamongkol T, Boonyawan D. The Healing Effect of Low-Temperature Atmospheric-Pressure Plasma in Pressure Ulcer: A Randomized Controlled Trial. Int J Low Extrem Wounds. 2016 Dec;15(4):313-319. doi: 10.1177/1534734616665046. Epub 2016 Sep 20.
- Background: PubMed 32591594Mirpour S, Fathollah S, Mansouri P, Larijani B, Ghoranneviss M, Mohajeri Tehrani M, Amini MR. Cold atmospheric plasma as an effective method to treat diabetic foot ulcers: A randomized clinical trial. Sci Rep. 2020 Jun 26;10(1):10440. doi: 10.1038/s41598-020-67232-x.
- Background: PubMed 28843407Hartwig S, Preissner S, Voss JO, Hertel M, Doll C, Waluga R, Raguse JD. The feasibility of cold atmospheric plasma in the treatment of complicated wounds in cranio-maxillo-facial surgery. J Craniomaxillofac Surg. 2017 Oct;45(10):1724-1730. doi: 10.1016/j.jcms.2017.07.008. Epub 2017 Jul 27.
- Background: PubMed 20222930Isbary G, Morfill G, Schmidt HU, Georgi M, Ramrath K, Heinlin J, Karrer S, Landthaler M, Shimizu T, Steffes B, Bunk W, Monetti R, Zimmermann JL, Pompl R, Stolz W. A first prospective randomized controlled trial to decrease bacterial load using cold atmospheric argon plasma on chronic wounds in patients. Br J Dermatol. 2010 Jul;163(1):78-82. doi: 10.1111/j.1365-2133.2010.09744.x. Epub 2010 Mar 5.
- Background: PubMed 37568525Abu Rached N, Kley S, Storck M, Meyer T, Stucker M. Cold Plasma Therapy in Chronic Wounds-A Multicenter, Randomized Controlled Clinical Trial (Plasma on Chronic Wounds for Epidermal Regeneration Study): Preliminary Results. J Clin Med. 2023 Aug 4;12(15):5121. doi: 10.3390/jcm12155121.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) will be shared on a case by case basis with an Institutional data transfer agreement in place.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher C. Thompson, MD, MSc principal investigator
Brigham and Womens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Thermal Plasma (LTP) Treatment in people with Roux-en-y Anastomosis Site and Marginal Ulcer, run by Christopher C. Thompson, MD, MSc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele B Ryan, MS (617-525-8266, mryan@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer Healing Success Rate from baseline endoscopy (time frame: Baseline, 4 weeks, 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06543316, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.