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Comparison of Stent Suturing Versus OTSC Stentfix

NCT04936425 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-06-28

No results posted yet for this study

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

DEVICE

OTSC Stentfix

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

Sponsors & Collaborators

Principal Investigators

  • Gregory Haber, MD · NYU Langone Health

  • Lauren Khanna, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-21
Primary Completion
2024-07-31
Completion
2025-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04936425 on ClinicalTrials.gov