ObesityGMDNCT03526263
Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy
A study testing Gastric mucosal devitalization in people with Obesity and Obesity, Morbid, run by Johns Hopkins University at 1 site in United States.
Trial summary
Rapid metabolic improvements seen with sleeve gastrectomy are likely a result of changes in gastric origin. The gastric mucosa is an endocrine organ that regulates satiation pathways and is a complex regulator of food intake as well as lipid and glucose metabolism. Read more about this study
- Who is it for?
- Ages 28 to 60 years
- Conditions the study is for
- Obesity, Obesity, Morbid, Obesity; Endocrine
- What is being tested?
- Gastric mucosal devitalization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2018to 29 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 28 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled to undergo vertical sleeve gastrectomy
Who cannot join
- Age under 28 or older than 60
- Insulin dependent Diabetes Mellitus
- Suspected or biopsy confirmed liver cirrhosis
- Significant ethanol consumption >21 drinks/week in men and >14 drinks/week in women
- Presence of other chronic liver disease including hepatitis B-C, autoimmune hepatitis, alpha 1 antitrypsin deficiency, Wilson's disease, and hemochromatosis
- Pregnant or breast-feeding
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- Patients who already have an intragastric balloon or other gastric implant
- Patients with gastroesophageal reflux disease
- Patients with previous gastric surgeries, altered gastrointestinal anatomy such as Billroth I, Billroth II, roux-en-y gastrectomy, roux-en-y hepaticojejunostomy, or any restrictive or bypass bariatric surgery
- Patients with previous gastric embolization for obesity
- Presence of inflammatory disorder of the gastrointestinal tract
- Patients with active peptic ulcer disease
- Patients with gastroesophageal varices
- Presence of a large hiatal hernia (grade IV on Hills classification: large hiatal hernia and essentially no fold approximating the endoscope in the retroflexed view and where the lumen of the esophagus is gaping open allowing the squamous epithelium to be seen)
- Structural abnormality in the esophagus or pharynx
- Have major esophageal motility disorders as per the Chicago classification including achalasia, diffuse esophageal spasm, jackhammer esophagus, and Esophagogastric junction outflow obstruction
- Mucosal or submucosal gastric mass that is clinically suspected to be of malignant nature
- Severe clotting or bleeding disorder
- Other medical condition that does not allow for endoscopic procedure
- Severe psychiatric illness
- Unable to participate in routine medical follow-up
- On antiplatelet agents including clopidogrel, ticlopidine, prasugrel, and cangrelor. acetylsalicylic acid use will be allowed
- On anticoagulants including heparin, warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21202
About this study
Rapid metabolic improvements seen with sleeve gastrectomy are likely a result of changes in gastric origin. The gastric mucosa is an endocrine organ that regulates satiation pathways and is a complex regulator of food intake as well as lipid and glucose metabolism. This study aims to assess the efficacy and safety of endoscopic selective gastric mucosal devitalization (GMD) for the management of obesity and its related comorbidities.
Read the detailed description
Endoscopic approaches to obesity may help fulfill the unmet need of over half the US adult population that would benefit from therapy for obesity but are not receiving it. Endoscopic approaches to obesity have the potential to be more efficacious than antiobesity medications and have a lower risk-cost profile compared with bariatric surgery.
Endoscopic approaches to obesity need to be increasingly modeled on the proposed mechanisms contributing to the benefits of bariatric surgery.
The investigators seek to decipher if the gastric mucosa is an independent regulator of food intake, body weight, lipid and glucose metabolism and serum gut hormones. The investigators also wish to ascertain if selective devitalization of the gastric mucosa, without alteration in gastric volume, will improve obesity related comorbidities.
This study will be divided into 3 phases. The purpose of completing the 3 phases is to develop a minimally invasive weight loss technique that is effective, safe and ready for more rigorous assessment via a future randomized control trial.
Objectives:
Overall:
To assess the efficacy and safety of gastric mucosal devitalization for the management of obesity and its related comorbidities
Phase 1:
On an ex vivo specimen, identify the optimal color of the tissue indicating that the gastric mucosa has been sufficiently treated such that selective mucosal devitalization has occurred.
- Being tested
- Gastric mucosal devitalization
- Keywords
- Gastric Mucosal Devitalization, Obesity, Endoscopic Bariatric Therapies, Bariatric surgery
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric mucosal devitalizationProcedure or surgery
During routine laparoscopic sleeve gastrectomy surgery, once the greater curvature of the stomach is excised as per normal surgical technique, the investigators will take the specimen out and perform an ablation ex-vivo, with the intention of performing selective mucosal devitalization. This specimen will then be transported to pathology lab for analysis.
| Study group | Role | What they receive |
|---|---|---|
| Gastric mucosal devitalization arm | Experimental | Patients will be enrolled into the study after being scheduled to undergo vertical sleeve gastrectomy as part of routine clinical care at Johns Hopkins Bayview. The cost of the surgery will be covered by the patient's insurance and there will no extra procedural element that would add time to surgery.
The intervention will occur on the excised specimen ex vivo (outside the body) and will involve devitalization of the gastric mucosa using Argon Plasma Coagulation. Receives: Procedure: Gastric mucosal devitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selective mucosal devitalization color
Identify the optimal color of the tissue indicating that the gastric mucosa has been sufficiently treated such that selective mucosal devitalization has occurred (as determined by a pathologist examining the samples)
Measured: 6 months
Secondary outcomes (2)
Submucosal injection volume
Identify the optimal submucosal injection volume in milliliters required to facilitate selective mucosal devitalization (as determined by a pathologist examining the samples)
Measured: 6 months
Energy settings
Identify the optimal energy settings of argon plasma coagulation required to facilitate selective mucosal devitalization (as determined by a pathologist examining the samples)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start7 Jun 2018
- Primary completion29 Nov 2018
- Study completion29 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Erbe USA Incorporated
- Responsible party
- Sponsor
- Investigators
- Vivek Kumbhari, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526263
- Sponsor's protocol ID
- IRB00089675
- Acronym
- GMD
- Status last verified
- Sep 2019
- First submitted
- 16 Apr 2018
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy
- ClinicalTrials.gov ID
- NCT03526263
- Acronym / sponsor ID
- GMD / IRB00089675
- Keywords
- Gastric Mucosal Devitalization, Obesity, Endoscopic Bariatric Therapies, Bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Erbe USA Incorporated
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 16 May 2018 (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.
Rapid metabolic improvements seen with sleeve gastrectomy are likely a result of changes in gastric origin. The gastric mucosa is an endocrine organ that regulates satiation pathways and is a complex regulator of food intake as well as lipid and glucose metabolism. This study aims to assess the efficacy and safety of endoscopic selective gastric mucosal devitalization (GMD) for the management of obesity and its related comorbidities.
Detailed description
Endoscopic approaches to obesity may help fulfill the unmet need of over half the US adult population that would benefit from therapy for obesity but are not receiving it. Endoscopic approaches to obesity have the potential to be more efficacious than antiobesity medications and have a lower risk-cost profile compared with bariatric surgery.
Endoscopic approaches to obesity need to be increasingly modeled on the proposed mechanisms contributing to the benefits of bariatric surgery.
The investigators seek to decipher if the gastric mucosa is an independent regulator of food intake, body weight, lipid and glucose metabolism and serum gut hormones. The investigators also wish to ascertain if selective devitalization of the gastric mucosa, without alteration in gastric volume, will improve obesity related comorbidities.
This study will be divided into 3 phases. The purpose of completing the 3 phases is to develop a minimally invasive weight loss technique that is effective, safe and ready for more rigorous assessment via a future randomized control trial.
Objectives:
Overall:
To assess the efficacy and safety of gastric mucosal devitalization for the management of obesity and its related comorbidities
Phase 1:
On an ex vivo specimen, identify the optimal color of the tissue indicating that the gastric mucosa has been sufficiently treated such that selective mucosal devitalization has occurred.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric mucosal devitalization arm | Experimental | Procedure: Gastric mucosal devitalizationPatients will be enrolled into the study after being scheduled to undergo vertical sleeve gastrectomy as part of routine clinical care at Johns Hopkins Bayview. The cost of the surgery will be covered by the patient's insurance and there will no extra procedural element that would add time to surgery. The intervention will occur on the excised specimen ex vivo (outside the body) and will involve devitalization of the gastric mucosa using Argon Plasma Coagulation. |
Who may qualify
- Ages
- 28 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients scheduled to undergo vertical sleeve gastrectomy
Key exclusion criteria (23 listed)
- Age under 28 or older than 60
- Insulin dependent Diabetes Mellitus
- Suspected or biopsy confirmed liver cirrhosis
- Significant ethanol consumption >21 drinks/week in men and >14 drinks/week in women
- Presence of other chronic liver disease including hepatitis B-C, autoimmune hepatitis, alpha 1 antitrypsin deficiency, Wilson's disease, and hemochromatosis
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 |
|---|---|---|
| Gastric mucosal devitalizationDuring routine laparoscopic sleeve gastrectomy surgery, once the greater curvature of the stomach is excised as per normal surgical technique, the investigators will take the specimen out and perform an ablation ex-vivo, with the intention of performing selective mucosal devitalization. This specimen will then be transported to pathology lab for analysis. | Procedure or surgery | Gastric mucosal devitalization arm |
Primary outcome
Selective mucosal devitalization color
Time frame: 6 months
Identify the optimal color of the tissue indicating that the gastric mucosa has been sufficiently treated such that selective mucosal devitalization has occurred (as determined by a pathologist examining the samples)
2 secondary outcomes
Submucosal injection volume
Time frame: 6 months
Energy settings
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
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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. This study is not recruiting at the moment.
Vivek Kumbhari, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric mucosal devitalization in people with Obesity and Obesity, Morbid, run by Johns Hopkins University 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 1 inclusion and 23 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: finished, as of the sponsor's last update on 24 Sep 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selective mucosal devitalization color (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2019.