Preventing Esophageal Stent Migration in Esophageal Strictures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Stent Migration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Subjects will be blinded as to which study arm they are in, in order to avoid any bias they may have.

Study Groups

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No fixation

Group Type NO_INTERVENTION

No interventions assigned to this group

Stent Suturing

Group Type ACTIVE_COMPARATOR

Stent Suturing / Endoscopic Clips

Intervention Type PROCEDURE

Stent placement with fixation of the esophageal stent using sutures / endoscopic clips.

OTSC Stentfix

Group Type EXPERIMENTAL

OTSC Stentfix

Intervention Type DEVICE

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

Interventions

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OTSC Stentfix

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

Intervention Type DEVICE

Stent Suturing / Endoscopic Clips

Stent placement with fixation of the esophageal stent using sutures / endoscopic clips.

Intervention Type PROCEDURE

Eligibility Criteria

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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.