NCT04925271

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

Completed NA Results posted Last updated 28 June 2023

What this trial tests

NA trial testing X-Tack in Polyp of Colon in 40 participants. Completed in 30 July 2022.

Timeline

1 July 2021

Primary endpoint
30 June 2022

30 July 2022

Quick facts

Lead sponsor	Thomas Jefferson University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	1 July 2021
Primary completion	30 June 2022
Estimated completion	30 July 2022
Sites	1 location across United States

Drugs / interventions tested

• X-Tack
• Overstitch

Conditions studied

• Polyp of Colon — all drugs for Polyp of Colon →
• Fistula — all drugs for Fistula →

Sponsor

Thomas Jefferson University

Who can join

18 and older, any sex, with Polyp of Colon or Fistula. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Closure Primary · At time of endoscopy

The time required to close the defect using the device

Group	Value	95% CI
X-Tack	23.3	± 13.9
Overstitch	18.4	± 16.9

Incomplete Closure Secondary · At time of endoscopy

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

Group	Value	95% CI
X-Tack	2
Overstitch	3

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

X-Tack

Serious: 2/20 (10%)

Deaths: 0/20

Overstitch

Serious: 0/20 (0%)

Deaths: 0/20

Serious adverse events (1 terms)

Reaction	System	X-Tack	Overstitch
Delayed bleeding	Gastrointestinal disorders	—	—

Most-reported serious reactions: Delayed bleeding.

Data from ClinicalTrials.gov NCT04925271 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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).
   Agnihotri A, Agnihotri A, Mitsuhashi S, Holmes I, et al · · 2024 · cited 14× · PMID 37536633 · DOI 10.1016/j.gie.2023.07.046