Comparison of no Fixation vs. Stent Suturing vs. OTSC Stentfix in Preventing Esophageal Stent Migration in Esophageal Strictures

NYU Langone Health1 site in 1 countryFebruary 2023

ConditionsStent Migration

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stent Migration
Sponsor: NYU Langone Health
Locations: 1
Primary Endpoint: Number of Participants who Experience Stent Migration
Status: Withdrawn
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to assess the efficacy and rate of stent migration in standard of care esophageal stents that are not fixed, compared to those that are fixed with either standard of care OTSC stentfix or standard of care stent placement with suturing in both benign and malignant esophageal strictures.

Registry

clinicaltrials.gov

Start Date

February 2023

End Date

September 30, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NYU Langone Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The study population will include any adult (18 years +) who will undergo standard of care esophageal stent placement for benign or malignant esophageal strictures as either an inpatient or outpatient at NYULH.
•The participant is able to consent to stent placements with fixation or without fixation and study procedures, verified by signature on the informed consent form.
•Willing to comply with all study procedures and be available for the duration of the study.
•English and Non-English speaking participants.