Preventing Esophageal Stent Migration in Esophageal Strictures

NYU Langone Health

Status: Withdrawn

Conditions: Stent Migration

Treatments: Device: OTSC Stentfix; Procedure: Stent Suturing / Endoscopic Clips

Study type: Interventional

Funder types: Other

Identifiers

NCT05081752

20-01901

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups

No fixation

No Intervention group

Stent Suturing

Active Comparator group

Treatment:

Procedure: Stent Suturing / Endoscopic Clips

OTSC Stentfix

Experimental group

Treatment:

Device: OTSC Stentfix