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Preventing Esophageal Stent Migration in Esophageal Strictures

NCT05081752 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-04-10

No results posted yet for this study

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.

Conditions

  • Stent Migration

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Gregory Haber, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2024-09-30
Completion
2025-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05081752 on ClinicalTrials.gov