Closure of Mucosal and Submucosal Defects in the Gastrointestinal Tract Using the Novel X-Tack Endoscopic Suturing Device

Study Overview
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Brief Summary
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After removing large polyps from the gastrointestinal tract, gastroenterologists close the new defect with devices to prevent complications like bleeding or the development of a leak. Commonly, this is done with a device called Overstitch, which allows the gastroenterologist to stitch the defect with an endoscope. A new device called X-tack has been developed to simplify endoscopic stitching. In this study, the new X-tack device will be compared to Overstitch when closing defects in the gastrointestinal tract. The two devices will be compared to see how long it takes to close a defect, as well as if there are any differences in complications like bleeding or infection.

Detailed Description
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Currently, the community standard is that gastroenterologists who are familiar with Overstitch start using the X-Tack without additional training. However, a hands-on demonstration session with the X-Tack device in a dry lab has been conducted with each endoscopist in the trial prior to the study in order to familiarize them with device before enrollment. Each endoscopist has also participated in a wet lab using an explant (porcine stomach) to simulate in vivo closure of defects using the X-Tack system. The device operates in a similar fashion compared to previous suturing devices, which are used frequently by all endoscopists involved in this study. On this basis, all endoscopists in the study report comfort and familiarity with the X-Tack system, and the break-in period is not anticipated to affect safety or results during the study. The primary study visit will be comprised of the endoscopic procedure at the time of defect closure and a telephone call 48-72 hours later to assess for complications. Patient will be enrolled in the pre-procedure area. If the patient has a pre-procedure visit, they may be notified of their potential for enrollment in the study at that time, though not all patients have a pre-procedure visit in our practice. Patients will be randomized to closure with the X-Tack system versus closure with the Overstitch system prior to their procedure using a centralized computer-generated randomization. Technical success of closure, time of closure, number of sutures required, need for alternative modalities for closure, and any intraprocedural complications (bleeding, perforation) will be recorded. Any patient with possible periprocedural perforation will receive antibiotics at the endoscopist's discretion. At the endoscopist's discretion, the patient may cross over during the procedure to the other group if they believe that their current closure strategy is failing to safely close the defect. Alternate methods of closure (TTS clips, over-the-scope clips) may be used in either group if required by the endoscopist for safe closure of the defect. After the procedure, most patients are observed in the recovery area for 1-2 hours for any signs of complications before they are discharged home.

Official Title
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Closure of Mucosal and Submucosal Defects in the Gastrointestinal Tract Using the Novel X-Tack Endoscopic Suturing Device

Conditions
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Fistula, Polyp of Colon

Intervention / Treatment
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* Device: X-Tack
* Device: Overstitch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years of age Undergoing closure of a gastrointestinal luminal defect for which a suturing device would be otherwise indicated Exclusion Criteria: INR > 2 Platelets < 150 Ongoing anticoagulation not meeting ASGE Antithrombotic Guidelines (Acosta RD et al, The Management of Antithrombotic Agents for Patients Undergoing GI Endoscopy, Gastrointest Endosc, 2016; 83(1): 3-16) Hemodynamic instability Ongoing or anticipated pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients undergoing closure of a mucosal or submucosal defect in the gastrointestinal tract will be randomized 1:1 to either closure with X-Tack or closure with Overstitch.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: X-Tack<br>The gastrointestinal tract mucosal or submucosal defect is closed using the X-Tack device. | Device: X-Tack<br>* The mucosal or submucosal defect is closed with X-Tack.<br>|
| Active Comparator: Overstitch<br>The gastrointestinal tract mucosal or submucosal defect is closed using the Overstitch device. | Device: Overstitch<br>* The mucosal or submucosal defect is closed with Overstitch.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Closure | The time required to close the defect using the device | At time of endoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incomplete Closure | Either crossover to the other study group per endoscopist's discretion, or the need for additional modalities to close the defect such as endoscopic clips | At time of endoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic submucosal dissection, Suturing