Preventing Esophageal Stent Migration in Esophageal Strictures

Not Applicable

Withdrawn

• Conditions: Stent Migration
• Interventions: Procedure: Stent Suturing / Endoscopic Clips; Device: OTSC Stentfix

• Registration Number: NCT05081752
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-18
• Study Start: 2023-02
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-10
• Primary Completion: 2024-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: WITHDRAWN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

Inclusion Criteria

1. 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.
2. 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.
3. Willing to comply with all study procedures and be available for the duration of the study.
4. English and Non-English speaking participants.

Exclusion Criteria

1. Patients who have strictures treated with luman apposing stents.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stent Suturing	Stent Suturing / Endoscopic Clips	-
OTSC Stentfix	OTSC Stentfix	-

Primary Outcome Measures

Name	Time	Method
Number of Participants who Experience Stent Migration	Week 48

Secondary Outcome Measures

Name	Time	Method
Total Procedural Time	120 minutes	Time it takes to complete standard of care upper endoscopy with standard of care stent placement with or without fixation.
Change in Score on Dysphagia Outcome and Severity Scale (DOSS)	Baseline, Week 48	DOSS is a simple, easy-to-use, 7-point scale developed to systematically rate the functional severity of dysphagia. The total range of score is 1-7; a lower score indicates more severe symptoms of dysphagia.

Trial Locations

Locations (1)

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