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Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment

NCT02751333 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-05-15

No results posted yet for this study

Summary

Esophageal stents are commonly used for benign esophageal pathology, especially strictures or esophageal mucosal defects such as leaks, fistulae, or perforations. The major limiting factor to stent placement is the high migration rate of the stent. Investigators are trying to prospectively evaluate the efficacy of endostitch in preventing stent migration in benign esophageal disease in comparison with standard, fully covered self-expanding metal stents (FCSEMS) placement without fixation.

Conditions

  • Esophageal Strictures
  • Esophageal Leak
  • Esophageal Perforation
  • Esophageal Fistula
  • Endostitch
  • Esophageal Stent

Interventions

PROCEDURE

FCSEMS with Endostitch (ES)

The fixation of FCSEMS using endostitch (ES) with the OverStitchTM system to prevent migration.

PROCEDURE

FCSEMS with No Suturing (NS)

The insertion of FCSEMS with no suturing.

DEVICE

Fully Covered Self-Expanding Metal Stents (FCSEMS)

This is the stent that will be used to treat the esophageal pathology in both groups

DEVICE

EndoStitch (ES) with the OverStitchTM system

This is the device used to apply the stitches to the stent in participants randomized to stent suturing.

Sponsors & Collaborators

Principal Investigators

  • Mouen Khashab, M.D. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-02-28
Completion
2017-02-28

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 NCT02751333 on ClinicalTrials.gov