Preventing Esophageal Stent Migration in Esophageal Strictures

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05081752

Enrollment

Registered

2021-10-18

Start date

2023-02-28

Completion date

2025-09-30

Last updated

2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stent Migration

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.

Interventions

DEVICEOTSC Stentfix

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

PROCEDUREStent Suturing / Endoscopic Clips

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Number of Participants who Experience Stent Migration	Week 48

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026