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

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.

Study Overview

• Status: Completed
• Conditions: Fistula; Polyp of Colon
• Intervention / Treatment: Device: X-Tack; Device: Overstitch

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Anand Kumar, MD MPH, Thomas Jefferson University

Publications and helpful links

General Publications

• Kothari ST, Huang RJ, Shaukat A, Agrawal D, Buxbaum JL, Abbas Fehmi SM, Fishman DS, Gurudu SR, Khashab MA, Jamil LH, Jue TL, Law JK, Lee JK, Naveed M, Qumseya BJ, Sawhney MS, Thosani N, Yang J, DeWitt JM, Wani S; ASGE Standards of Practice Committee Chair. ASGE review of adverse events in colonoscopy. Gastrointest Endosc. 2019 Dec;90(6):863-876.e33. doi: 10.1016/j.gie.2019.07.033. Epub 2019 Sep 25.
• Pohl H, Grimm IS, Moyer MT, Hasan MK, Pleskow D, Elmunzer BJ, Khashab MA, Sanaei O, Al-Kawas FH, Gordon SR, Mathew A, Levenick JM, Aslanian HR, Antaki F, von Renteln D, Crockett SD, Rastogi A, Gill JA, Law RJ, Elias PA, Pellise M, Wallace MB, Mackenzie TA, Rex DK. Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial. Gastroenterology. 2019 Oct;157(4):977-984.e3. doi: 10.1053/j.gastro.2019.03.019. Epub 2019 Mar 15.
• Qumseya BJ, Wolfsen C, Wang Y, Othman M, Raimondo M, Bouras E, Wolfsen H, Wallace MB, Woodward T. Factors associated with increased bleeding post-endoscopic mucosal resection. J Dig Dis. 2013 Mar;14(3):140-6. doi: 10.1111/1751-2980.12002.
• Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
• Kantsevoy SV, Bitner M, Mitrakov AA, Thuluvath PJ. Endoscopic suturing closure of large mucosal defects after endoscopic submucosal dissection is technically feasible, fast, and eliminates the need for hospitalization (with videos). Gastrointest Endosc. 2014 Mar;79(3):503-7. doi: 10.1016/j.gie.2013.10.051. Epub 2013 Dec 12.
• Zhang QS, Han B, Xu JH, Gao P, Shen YC. Clip closure of defect after endoscopic resection in patients with larger colorectal tumors decreased the adverse events. Gastrointest Endosc. 2015 Nov;82(5):904-9. doi: 10.1016/j.gie.2015.04.005. Epub 2015 May 12.
• ASGE Standards of Practice Committee; Acosta RD, Abraham NS, Chandrasekhara V, Chathadi KV, Early DS, Eloubeidi MA, Evans JA, Faulx AL, Fisher DA, Fonkalsrud L, Hwang JH, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Shaukat A, Shergill AK, Wang A, Cash BD, DeWitt JM. The management of antithrombotic agents for patients undergoing GI endoscopy. Gastrointest Endosc. 2016 Jan;83(1):3-16. doi: 10.1016/j.gie.2015.09.035. Epub 2015 Nov 24. No abstract available. Erratum In: Gastrointest Endosc. 2016 Mar;83(3):678.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Endoscopic submucosal dissection; Suturing
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Fistula; Colonic Polyps
• Other Study ID Numbers: 21D.166

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in any publications from the trial after deidentification (text, tables, figures and appendices) will be made available upon request.
• IPD Sharing Time Frame: Immediately following publication, no end date.
• IPD Sharing Access Criteria: Proposals should be directed to anand.kumar@jefferson.edu.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes