CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
X-Tack +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04925271
NCT04925271N/ACompleted

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

Thomas Jefferson University·interventional·Posted Jun 14, 2021·Updated Jun 28, 2023

In Brief

A clinical study evaluating X-Tack and Overstitch for Polyp of Colon and Fistula. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 14, 2021
Enrollment StartJul 1, 2021
Primary CompletionJun 30, 2022
Study CompletionJul 30, 2022
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 5.0 years ago

Interventions

X-Tackdevice

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

Overstitchdevice

The mucosal or submucosal defect is closed with Overstitch.