Gastrointestinal NeoplasmsNCT05163665
Cost-effective Analysis of Two Approximation Devices in Closure of Gastrointestinal Defects
A study testing Closure type in people with Gastrointestinal Neoplasms, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This is a prospective, randomized research trial that aims to evaluate the clinical results of two different approximation methods to close the tissue defect caused by removing gastrointestinal polyps. 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?
- Closure type
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2022to 11 Sep 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is greater than or equal to 18 years of age.
- Patient can provide informed consent.
- Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric, small bowel, or colorectal lesion.
- Post resection defect > 3cm.
- Lesion 2cm or greater from the dentate line.
Who cannot join
- Patient is < 18 years of age.
- Patient refused and/or unable to provide consent.
- Patient is pregnant.
- Patient is currently incarcerated
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, randomized research trial that aims to evaluate the clinical results of two different approximation methods to close the tissue defect caused by removing gastrointestinal polyps.
Read the detailed description
Closure of GI defects after endoscopic resection decreases the rate of post resection bleeding. Traditionally, standard TTS clips have been used to close GI wall defects with some success. However, complete apposition of the resection wall edges occurs only 68% of the time. Endoscopic suturing with the traditional Overstitch device can achieve complete closure in almost 100% of defects. However, this device is costly, requires the use of a double channel therapeutic endoscope, and at times can be difficult to maneuver. Recently, a novel FDA approved TTS tissue helix and suture device (X-tack) was developed to overcome the challenges of the traditional Overstitch device. Animal models have demonstrated the X-tack system is superior to TTS in effecting large mucosal defects and maintain similar durability. At BCM, we have been using the X-tack system routinely in closure of GI defects.
- Conditions
- Gastrointestinal Neoplasms
- Being tested
- Closure type
- Keywords
- Closure of GI defects
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure typeProcedure or surgery
Patients will have their endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) as per standard-of-care. Afterwards, patient will receive one of two intervention options for the closure of the GI defect following polyp removal.
| Study group | Role | What they receive |
|---|---|---|
| Through-the-Scope clip group | Experimental | Through the scope Dual Action Tissue Clip (DAT) clipping equipment and technique performed in closure of GI defect area after polyp removal. Receives: Procedure: Closure type |
| X-Tack suturing group | Active comparator | Use of Endoscopic Helix Tacking System (X-Tack) by Apollo Endosurgery for the closure of GI defect after polyp removal. Receives: Procedure: Closure type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of each closure
Total cost amount for equipment used in closure of GI defect
Measured: Day 1
Secondary outcomes (2)
Rate of complete closure of GI defect
Complete closure achieved by assigned closure type as assessed by performing physician
Measured: Day 1 (end of procedure)
Successful Tissue approximation
Less than or equal to 15mm of visible resection bed at its widest portion after the device is used for tissue approximation
Measured: Day 1 (End of procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start23 Aug 2022
- Primary completion15 Aug 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
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
- NCT05163665
- Sponsor's protocol ID
- H-50701
- Status last verified
- Feb 2024
- First submitted
- 1 Dec 2021
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jawaid S, Khalaf M, Ayoub F, Zabad N, Fikry A, Daba G, Mercado M, Keihanian T, Othman M. RCT comparing the clinical efficacy and costs of two tissue approximation devices in the closure of large post-endoscopic resection defects. Surg Endosc. 2025 Aug;39(8):5442-5453. doi: 10.1007/s00464-025-11876-1. Epub 2025 Jul 10.
PubMed 40640617
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effective Analysis of Two Approximation Devices in Closure of Gastrointestinal Defects
- ClinicalTrials.gov ID
- NCT05163665
- Acronym / sponsor ID
- H-50701
- Conditions
- Gastrointestinal Neoplasms
- Keywords
- Closure of GI defects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 20 Dec 2021 (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.
This is a prospective, randomized research trial that aims to evaluate the clinical results of two different approximation methods to close the tissue defect caused by removing gastrointestinal polyps.
Detailed description
Closure of GI defects after endoscopic resection decreases the rate of post resection bleeding. Traditionally, standard TTS clips have been used to close GI wall defects with some success. However, complete apposition of the resection wall edges occurs only 68% of the time. Endoscopic suturing with the traditional Overstitch device can achieve complete closure in almost 100% of defects. However, this device is costly, requires the use of a double channel therapeutic endoscope, and at times can be difficult to maneuver. Recently, a novel FDA approved TTS tissue helix and suture device (X-tack) was developed to overcome the challenges of the traditional Overstitch device. Animal models have demonstrated the X-tack system is superior to TTS in effecting large mucosal defects and maintain similar durability. At BCM, we have been using the X-tack system routinely in closure of GI defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Through-the-Scope clip group | Experimental | Procedure: Closure typeThrough the scope Dual Action Tissue Clip (DAT) clipping equipment and technique performed in closure of GI defect area after polyp removal. |
| X-Tack suturing group | Active comparator | Procedure: Closure typeUse of Endoscopic Helix Tacking System (X-Tack) by Apollo Endosurgery for the closure of GI defect after polyp removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is greater than or equal to 18 years of age.
- Patient can provide informed consent.
- Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric, small bowel, or colorectal lesion.
- Post resection defect > 3cm.
- Lesion 2cm or greater from the dentate line.
Key exclusion criteria (4 listed)
- Patient is < 18 years of age.
- Patient refused and/or unable to provide consent.
- Patient is pregnant.
- Patient is currently incarcerated
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 |
|---|---|---|
| Closure typePatients will have their endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) as per standard-of-care. Afterwards, patient will receive one of two intervention options for the closure of the GI defect following polyp removal. | Procedure or surgery | Through-the-Scope clip group, X-Tack suturing group |
Primary outcome
Cost of each closure
Time frame: Day 1
Total cost amount for equipment used in closure of GI defect
2 secondary outcomes
Rate of complete closure of GI defect
Time frame: Day 1 (end of procedure)
Successful Tissue approximation
Time frame: Day 1 (End of procedure)
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 15 Feb 2024.
- Derived from this study: PubMed 40640617Jawaid S, Khalaf M, Ayoub F, Zabad N, Fikry A, Daba G, Mercado M, Keihanian T, Othman M. RCT comparing the clinical efficacy and costs of two tissue approximation devices in the closure of large post-endoscopic resection defects. Surg Endosc. 2025 Aug;39(8):5442-5453. doi: 10.1007/s00464-025-11876-1. Epub 2025 Jul 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure type in people with 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 5 inclusion and 4 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 15 Feb 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?
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?
Cost of each closure (time frame: Day 1). 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 NCT05163665, which also lists 1 linked publication.
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 15 Feb 2024.