Comparison of Stent Suturing Versus OTSC Stentfix

Not Applicable

Withdrawn

• Conditions: Esophageal Stent Fixation
• Interventions: Device: OTSC Stentfix

• Registration Number: NCT04936425
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this study is to investigate whether OTSC stentfix is a feasible, safe, and efficient device that can be used for esophageal stent fixation (to prevent stent migration) in patients with benign, non-stricture esophageal lesions, including leaks, perforation, and fistulae. Currently, self-expandable metal stents (SEMS) have a risk of migration which can lead to adverse events such as bleeding and perforation. There has been clinical experience demonstrating that stent suturing can prevent stent migration. However, stent suturing can significantly increase endoscopic procedural time. The use of OTSC stentfix for stent fixation is promising as it is likely less time-consuming and less technically difficult, with likely a similar rate of fixation and migration. This non-inferiority study aims to investigate how OTSC stentfix functions as compared to stent suturing. If OTSC stentfix is at least comparable to stent suturing, it can reduce endoscopy procedural times, minimize peri-endoscopic risks, and minimize adverse events related to stent migration.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-16
• Study First Posted: 2021-06-23
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-26
• Last Update Posted: 2023-06-28
• Study Start: 2023-07-21
• Primary Completion: 2024-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• All adults (18+ years)
• Have benign, non-stricture esophageal lesions (i.e. fistulae, perforation, leaks) warranting esophageal stent placement as an inpatient or outpatient
• Ability to consent to stent fixation.

Exclusion Criteria

• < 18 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OTSC Stentfix	OTSC Stentfix	-

Primary Outcome Measures

Name	Time	Method
Average rate of stent migration	48 weeks

Secondary Outcome Measures

Name	Time	Method
Procedural time needed for stent fixation	120 minutes
Duration of time until stent migration for stents that fail fixation	48 weeks

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States