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

NCT04925271 | Completed Results DMC FDA Device

• 1 other identifier: 21D.166
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polyp of Colon; Fistula

Keywords

Endoscopic submucosal dissection; Suturing

Outcome Measures

Primary Outcomes (1)

• Time to Closure

  The time required to close the defect using the device

  At time of endoscopy

Secondary Outcomes (1)

• Incomplete Closure

  At time of endoscopy

Study Arms (2)

X-Tack

EXPERIMENTAL

The gastrointestinal tract mucosal or submucosal defect is closed using the X-Tack device.

Device: X-Tack

Overstitch

ACTIVE COMPARATOR

The gastrointestinal tract mucosal or submucosal defect is closed using the Overstitch device.

Device: Overstitch

Interventions

X-Tack DEVICE

The mucosal or submucosal defect is closed with X-Tack.

X-Tack

Overstitch DEVICE

The mucosal or submucosal defect is closed with Overstitch.

Overstitch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years of age
• Undergoing closure of a gastrointestinal luminal defect for which a suturing device would be otherwise indicated

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (8)

• 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.

  PMID: 31563271 BACKGROUND

• 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.

  PMID: 30885778 BACKGROUND

• 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.

  PMID: 23134152 BACKGROUND

• 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.

  PMID: 20189503 BACKGROUND

• 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.

  PMID: 24332082 BACKGROUND

• 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.

  PMID: 25975527 BACKGROUND

• 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.

  PMID: 26621548 BACKGROUND

• Agnihotri A, Mitsuhashi S, Holmes I, Kamal F, Chiang A, Loren DE, Kowalski TE, Schlachterman A, Kumar AR. Randomized trial of gastric and colorectal endoscopic submucosal dissection defect closure comparing a novel through-the-scope suturing system with an over-the-scope suturing system (with video). Gastrointest Endosc. 2024 Feb;99(2):237-244.e1. doi: 10.1016/j.gie.2023.07.046. Epub 2023 Aug 1.

  PMID: 37536633 DERIVED

MeSH Terms

Conditions

Colonic Polyps; Fistula

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anand Kumar, Associate Professor of Medicine
• Organization: Thomas Jefferson University

anand.kumar@jefferson.edu

215-955-8900

Study Officials

• Anand Kumar, MD MPH

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 14, 2021
• Study Start: July 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: June 28, 2023
• Results First Posted: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately following publication, no end date.
• Access Criteria: Proposals should be directed to anand.kumar@jefferson.edu.

Locations

US (1)