Gastrointestinal NeoplasmsNCT06747988
Feasibility and Prospective Study of a Dynamic Traction Device for Use During ESD
An observational study of Gastrointestinal Neoplasms, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The goal of this prospective study at Baylor St. Luke's Medical Center is to investigate the the efficacy and safety of using the novel TTS helix tack suture device as a dynamic traction device during colon and gastric endoscopic submucosal dissection (ESD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasms
- What is being tested?
- Traction Device
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2025to 20 Jul 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients undergoing ESD procedure at Baylor St. Luke's Medical Center - Houston, TX.
Who may be able to join
- The patient is ≥ 18 years old.
- Patients can provide informed consent.
- The patient is referred for ESD procedure of colonic or gastric neoplastic lesions and with one of the following criteria:
- A- Lesions with prior failed resection of any size. B- Granular lateral spreading tumors (GLST) more than 30 mm. C- Non granular lateral spreading tumors (NGLST) more than 20 mm. D- Any lesion with suspected superficial submucosal invasion. E- Subepithelial lesions.
Who cannot join
- The patient is < 18 years old.
- The patient refuses and/or is unable to provide consent.
- The patient is a pregnant woman.
- Lesions with morphology: pedunculated type (Paris Ip, Ips).
- Appendiceal orifice or IC valve lesions
- Patients with lesions removed with other techniques besides ESD (submucosal tunneling technique [STER] or EMR).
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
Baylor College of Medicine
Houston, Texas, 77030
Mai Khalaf, MD, 713-798-6696, mai.khalaf@bcm.edu
Michael Mercado, 713-798-3606, Michael.Mercado@bcm.edu
About this study
Official title: Prospective Study Evaluating the Use of a Novel Through - the- Scope Suturing System as a Dynamic Traction Device During ESD: A Feasibility Study
The goal of this prospective study at Baylor St. Luke's Medical Center is to investigate the the efficacy and safety of using the novel TTS helix tack suture device as a dynamic traction device during colon and gastric endoscopic submucosal dissection (ESD). The investigators of this study hypothesize that a dynamic traction during ESD can be less traumatic than with other traction devices.
Read the detailed description
Endoscopic submucosal dissection (ESD) is the mainstay of treatment for complex gastrointestinal polyps, particularly those with a higher risk of superficial submucosal invasion. To facilitate endoscopic dissection, traction is frequently used, particularly in tough locations or when fibrosis is present [1]. Traction assisted ESD is particularly attractive when other techniques, such as tunneling or pocket formation, are not effective.
Tissue traction can be applied by several methods including gravity, mucosal tension, water pressure, and adjusting the patient's body position [2]. Additionally, traction can also be applied using devices such as clip and line, snare, band assisted or using dedicated over-the-scope devices, which can be cumbersome and costly. Despite multiple publications about the efficacy of traction devices in the East, there are few published data from the West [3]. Furthermore, an easy to use through the scope (TTS) dynamic traction device has yet to be developed. Recently, a novel TTS helix tack and suture device (X-tack, Apollo Endosurgery, Austin, Tex, USA) was FDA approved to help facilitate closure of post-resection defects [4]. However, clinical experience suggests the tack and suture system can also be used as a form of dynamic traction during ESD, similar to effective techniques using traditional suture-pulley systems for countertraction during ESD [5]. The traditional suture-pulley system, however, can be cumbersome to assemble as multiple parts are needed to configure it appropriately [6]. Additionally, attaching the suture to the designated areas requires use of multiple costly clips and if repositioning is needed, removal of the clip can be traumatic to the tissue. With the novel TTS suture system (X-tack), four tacks are already assembled along one suture line, thus a suture-pulley countertraction system can be employed without having to assemble multiple parts. In addition, the degree and angulation of traction can be altered simply by pulling, releasing or even redirecting the suture towards a different axis, supporting a dynamic traction during ESD. Finally, removal of the tack, if required, can be less traumatic than with other traction devices. Despite its potential advantages, use of X-tack as countertraction pulley system during ESD has not been formally studied. We looked to investigate the efficacy and safety of using the novel TTS helix tack suture device as a dynamic traction device during colon and gastric ESD.
- Conditions
- Gastrointestinal Neoplasms
- Being tested
- Traction Device
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traction DeviceDevice
After circumferential incision and trimming the submucosa at the incision's edge, dissection is initiated until approximately 20 to 30% of the anal side (for colonic lesions) or oral side (for gastric lesions) of lesion has been dissected leaving a flap of at least 1 cm in length. Once the mucosal flap is created the X-tack device is introduced through the endoscope channel. The first tack is placed on the opposite wall of the lesion, the 2nd and 3rd tack will then be placed next to each other on the mucosal flap portion of the lesion. The 4th tack does not have to be placed but can be used to generate further traction at any time. Clips can be placed along the suture and clipped to the wall at any point to change angulation of traction. The sutures can then be cut and released from the tissue
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Being able to dissect the lesion to facilitate en bloc removal (removal of the entire tumor endoscopically in one piece)
Measured: Day 1 (procedure day)
Secondary outcomes (7)
Dissection speed
Length of time to perform endoscopic submucosal dissection by the operator as measured by calculating area of lesion divided by time (cm^2/hours).
Measured: Day 1 (procedure day)
R0 and curative resection rates
As collected
Measured: Day 1 (procedure day)
Total procedure time
Total procedure time to perform ESD from scope in to scope out
Measured: Day 1 (procedure day)
NASA Task Load Index
Method assesses work load on five 7-point scales. Increments of high, medium and low
Measured: Day 1 (procedure day)
Intraprocedural adverse events
Such as musclaris propria injury and bleeding (related to or not related to the traction devices).
Measured: Day 1 (procedure day), up to 48 hours after procedure.
Post-procedural adverse events
As reported per subject follow-ups with the patient within 1 month.
Measured: 1 month post-procedure
Abdominal pain
Collected at 1 hour and 24 hours after procedure utilizing the Visual analogue scale (VAS)
Measured: 1 hour post-procedure, 24 hours post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start30 Mar 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion20 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salmaan Azam Jawaid, MD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747988
- Sponsor's protocol ID
- H-56820
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no expected significant increased risk associated with the use of the traction device in ESD beyond what the current standard is for the procedure. Loss of confidentiality is the only other risk associated with this project. All measures to ensure patient confidentiality will be employed. Data will be coded and entered into a password-protected computer. Only the Principal Investigator and Study Research Coordinators will have access to data with patient identifiers. There will be no disclosure of a patients protected health information. Paper copies of the study documents will be created only as needed and only shown to the investigators listed in the study. Once the study is completed, all paper copies will be destroyed. If the results of the study are published or used in any presentations, all patient related information will be coded.
Publications
Tanaka S, Terasaki M, Kanao H, Oka S, Chayama K. Current status and future perspectives of endoscopic submucosal dissection for colorectal tumors. Dig Endosc. 2012 May;24 Suppl 1:73-9. doi: 10.1111/j.1443-1661.2012.01252.x.
PubMed 22533757Othman MO, Jawaid SA, Rungta M, Sur N, Dhingra S. Double-balloon endolumenal intervention platform with flexible grasper to expedite colonic endoscopic submucosal dissection. VideoGIE. 2020 Dec 26;6(3):144-146. doi: 10.1016/j.vgie.2020.11.014. eCollection 2021 Mar. No abstract available.
PubMed 33738368Nagata M. Usefulness of underwater endoscopic submucosal dissection in saline solution with a monopolar knife for colorectal tumors (with videos). Gastrointest Endosc. 2018 May;87(5):1345-1353. doi: 10.1016/j.gie.2017.11.032. Epub 2017 Dec 12.
PubMed 29242059Hernandez A, Marya NB, Sawas T, Rajan E, Gades NM, Wong Kee Song LM, Abu Dayyeh BK, Buttar N, Storm AC. Gastrointestinal defect closure using a novel through-the-scope helix tack and suture device compared to endoscopic clips in a survival porcine model (with video). Endosc Int Open. 2021 Apr;9(4):E572-E577. doi: 10.1055/a-1370-9256. Epub 2021 Apr 12.
PubMed 33860074Ge PS, Thompson CC, Jirapinyo P, Aihara H. Suture pulley countertraction method reduces procedure time and technical demand of endoscopic submucosal dissection among novice endoscopists learning endoscopic submucosal dissection: a prospective randomized ex vivo study. Gastrointest Endosc. 2019 Jan;89(1):177-184. doi: 10.1016/j.gie.2018.08.032. Epub 2018 Aug 25.
PubMed 30148993Rieder E, Makris KI, Martinec DV, Swanstrom LL. The suture-pulley method for endolumenal triangulation in endoscopic submucosal dissection. Endoscopy. 2011;43 Suppl 2 UCTN:E319-20. doi: 10.1055/s-0030-1256774. Epub 2011 Oct 21. No abstract available.
PubMed 22020705Burgess NG, Bassan MS, McLeod D, Williams SJ, Byth K, Bourke MJ. Deep mural injury and perforation after colonic endoscopic mucosal resection: a new classification and analysis of risk factors. Gut. 2017 Oct;66(10):1779-1789. doi: 10.1136/gutjnl-2015-309848. Epub 2016 Jul 27.
PubMed 27464708
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating the Use of a Novel Through - the- Scope Suturing System as a Dynamic Traction Device During ESD: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06747988
- Acronym / sponsor ID
- H-56820
- Conditions
- Gastrointestinal Neoplasms
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 30 Mar 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 20 Jul 2026 (estimated)
- First posted
- 24 Dec 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 goal of this prospective study at Baylor St. Luke's Medical Center is to investigate the the efficacy and safety of using the novel TTS helix tack suture device as a dynamic traction device during colon and gastric endoscopic submucosal dissection (ESD). The investigators of this study hypothesize that a dynamic traction during ESD can be less traumatic than with other traction devices.
Detailed description
Endoscopic submucosal dissection (ESD) is the mainstay of treatment for complex gastrointestinal polyps, particularly those with a higher risk of superficial submucosal invasion. To facilitate endoscopic dissection, traction is frequently used, particularly in tough locations or when fibrosis is present [1]. Traction assisted ESD is particularly attractive when other techniques, such as tunneling or pocket formation, are not effective.
Tissue traction can be applied by several methods including gravity, mucosal tension, water pressure, and adjusting the patient's body position [2]. Additionally, traction can also be applied using devices such as clip and line, snare, band assisted or using dedicated over-the-scope devices, which can be cumbersome and costly. Despite multiple publications about the efficacy of traction devices in the East, there are few published data from the West [3]. Furthermore, an easy to use through the scope (TTS) dynamic traction device has yet to be developed. Recently, a novel TTS helix tack and suture device (X-tack, Apollo Endosurgery, Austin, Tex, USA) was FDA approved to help facilitate closure of post-resection defects [4]. However, clinical experience suggests the tack and suture system can also be used as a form of dynamic traction during ESD, similar to effective techniques using traditional suture-pulley systems for countertraction during ESD [5]. The traditional suture-pulley system, however, can be cumbersome to assemble as multiple parts are needed to configure it appropriately [6]. Additionally, attaching the suture to the designated areas requires use of multiple costly clips and if repositioning is needed, removal of the clip can be traumatic to the tissue. With the novel TTS suture system (X-tack), four tacks are already assembled along one suture line, thus a suture-pulley countertraction system can be employed without having to assemble multiple parts. In addition, the degree and angulation of traction can be altered simply by pulling, releasing or even redirecting the suture towards a different axis, supporting a dynamic traction during ESD. Finally, removal of the tack, if required, can be less traumatic than with other traction devices. Despite its potential advantages, use of X-tack as countertraction pulley system during ESD has not been formally studied. We looked to investigate the efficacy and safety of using the novel TTS helix tack suture device as a dynamic traction device during colon and gastric ESD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing ESD procedure at Baylor St. Luke's Medical Center - Houston, TX.
Key inclusion criteria (4 listed)
- The patient is ≥ 18 years old.
- Patients can provide informed consent.
- The patient is referred for ESD procedure of colonic or gastric neoplastic lesions and with one of the following criteria:
- A- Lesions with prior failed resection of any size. B- Granular lateral spreading tumors (GLST) more than 30 mm. C- Non granular lateral spreading tumors (NGLST) more than 20 mm. D- Any lesion with suspected superficial submucosal invasion. E- Subepithelial lesions.
Key exclusion criteria (6 listed)
- The patient is < 18 years old.
- The patient refuses and/or is unable to provide consent.
- The patient is a pregnant woman.
- Lesions with morphology: pedunculated type (Paris Ip, Ips).
- Appendiceal orifice or IC valve lesions
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 |
|---|---|---|
| Traction DeviceAfter circumferential incision and trimming the submucosa at the incision's edge, dissection is initiated until approximately 20 to 30% of the anal side (for colonic lesions) or oral side (for gastric lesions) of lesion has been dissected leaving a flap of at least 1 cm in length. Once the mucosal flap is created the X-tack device is introduced through the endoscope channel. The first tack is placed on the opposite wall of the lesion, the 2nd and 3rd tack will then be placed next to each other on the mucosal flap portion of the lesion. The 4th tack does not have to be placed but can be used to generate further traction at any time. Clips can be placed along the suture and clipped to the wall at any point to change angulation of traction. The sutures can then be cut and released from the tissue | Device | – |
Primary outcome
Technical success
Time frame: Day 1 (procedure day)
Being able to dissect the lesion to facilitate en bloc removal (removal of the entire tumor endoscopically in one piece)
7 secondary outcomes
Dissection speed
Time frame: Day 1 (procedure day)
R0 and curative resection rates
Time frame: Day 1 (procedure day)
Total procedure time
Time frame: Day 1 (procedure day)
NASA Task Load Index
Time frame: Day 1 (procedure day)
Intraprocedural adverse events
Time frame: Day 1 (procedure day), up to 48 hours after procedure.
Post-procedural adverse events
Time frame: 1 month post-procedure
Abdominal pain
Time frame: 1 hour post-procedure, 24 hours post-procedure.
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 24 Dec 2024.
- Results publication: PubMed 22533757Tanaka S, Terasaki M, Kanao H, Oka S, Chayama K. Current status and future perspectives of endoscopic submucosal dissection for colorectal tumors. Dig Endosc. 2012 May;24 Suppl 1:73-9. doi: 10.1111/j.1443-1661.2012.01252.x.
- Results publication: PubMed 33738368Othman MO, Jawaid SA, Rungta M, Sur N, Dhingra S. Double-balloon endolumenal intervention platform with flexible grasper to expedite colonic endoscopic submucosal dissection. VideoGIE. 2020 Dec 26;6(3):144-146. doi: 10.1016/j.vgie.2020.11.014. eCollection 2021 Mar. No abstract available.
- Results publication: PubMed 29242059Nagata M. Usefulness of underwater endoscopic submucosal dissection in saline solution with a monopolar knife for colorectal tumors (with videos). Gastrointest Endosc. 2018 May;87(5):1345-1353. doi: 10.1016/j.gie.2017.11.032. Epub 2017 Dec 12.
- Results publication: PubMed 33860074Hernandez A, Marya NB, Sawas T, Rajan E, Gades NM, Wong Kee Song LM, Abu Dayyeh BK, Buttar N, Storm AC. Gastrointestinal defect closure using a novel through-the-scope helix tack and suture device compared to endoscopic clips in a survival porcine model (with video). Endosc Int Open. 2021 Apr;9(4):E572-E577. doi: 10.1055/a-1370-9256. Epub 2021 Apr 12.
- Results publication: PubMed 30148993Ge PS, Thompson CC, Jirapinyo P, Aihara H. Suture pulley countertraction method reduces procedure time and technical demand of endoscopic submucosal dissection among novice endoscopists learning endoscopic submucosal dissection: a prospective randomized ex vivo study. Gastrointest Endosc. 2019 Jan;89(1):177-184. doi: 10.1016/j.gie.2018.08.032. Epub 2018 Aug 25.
- Results publication: PubMed 22020705Rieder E, Makris KI, Martinec DV, Swanstrom LL. The suture-pulley method for endolumenal triangulation in endoscopic submucosal dissection. Endoscopy. 2011;43 Suppl 2 UCTN:E319-20. doi: 10.1055/s-0030-1256774. Epub 2011 Oct 21. No abstract available.
- Results publication: PubMed 27464708Burgess NG, Bassan MS, McLeod D, Williams SJ, Byth K, Bourke MJ. Deep mural injury and perforation after colonic endoscopic mucosal resection: a new classification and analysis of risk factors. Gut. 2017 Oct;66(10):1779-1789. doi: 10.1136/gutjnl-2015-309848. Epub 2016 Jul 27.
- Individual participant dataSharing planned: No. There is no expected significant increased risk associated with the use of the traction device in ESD beyond what the current standard is for the procedure. Loss of confidentiality is the only other risk associated with this project. All measures to ensure patient confidentiality will be employed. Data will be coded and entered into a password-protected computer. Only the Principal Investigator and Study Research Coordinators will have access to data with patient identifiers. There will be no disclosure of a patients protected health information. Paper copies of the study documents will be created only as needed and only shown to the investigators listed in the study. Once the study is completed, all paper copies will be destroyed. If the results of the study are published or used in any presentations, all patient related information will be coded.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Neoplasms, run by Baylor College of Medicine 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 24 Dec 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: Day 1 (procedure day)). 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 NCT06747988, which also lists 7 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 24 Dec 2024.