Preventing Esophageal Stent Migration in Esophageal Strictures

Stent Migration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05081752
• Other study ID #: 20-01901
• Status: Withdrawn
• Phase: N/A
• Start date: February 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Stenosis
• Stent Migration

Intervention

Device:
• OTSC Stentfix
Stent placement with fixation of the esophageal stent using OTSC Stentfix.

Procedure:
• Stent Suturing / Endoscopic Clips
Stent placement with fixation of the esophageal stent using sutures / endoscopic clips.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants who Experience Stent Migration		Week 48
Secondary	Total Procedural Time	Time it takes to complete standard of care upper endoscopy with standard of care stent placement with or without fixation.	120 minutes
Secondary	Change in Score on Dysphagia Outcome and Severity Scale (DOSS)	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.	Baseline, Week 48