NCT04936425

Comparison of Stent Suturing Versus OTSC Stentfix

Comparison of Stent Suturing Versus OTSC Stentfix in Preventing Esophageal Stent Migration in Non-Stricture Esophageal Lesions

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Stent Fixation

Interventions

Type	Name	Description
DEVICE	OTSC Stentfix	The OTSC stentfix will be placed during upper endoscopy after a self-expanding metal stent has been deployed.

Timeline

• Start date: 2023-07-21
• Primary completion: 2024-07-31
• Completion: 2025-07-31
• First posted: 2021-06-23
• Last updated: 2023-06-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study