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Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease

NCT02395354 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2018-04-13

No results posted yet for this study

Summary

This study will be a multicentre randomized controlled trial to assess the efficacy between balloon dilatation and self-expanding metallic stent placement for endoscopic treatment of stenosis in Crohn´s Disease.

Conditions

Interventions

DEVICE

Placing a self-expanding metallic stent

* Income on short stay unit (SSU) post-procedure * Light sedation by the endoscopist vs anesthetist by center * Fully covered self-expanding metal stents Tae Woong Medical® type; prosthesis size at the endoscopist discretion * Clips can be placed at the distal end of the prosthesis according to the endoscopist. * Prosthesis removal time in 4 weeks.

DEVICE

A balloon dilatation

* Income on short stay unit (SSU) post-procedure * Light sedation by the endoscopist vs anesthetist by center. * Pneumatic ball type CRE Boston cientific®; balloon diameter at the endoscopist discretion * Up to 2 expansion will be made with a minimum interval between 15-30 days between each expansion * It shall be deemed failure to expansion if required\> 2 expansions.

Sponsors & Collaborators

  • Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

    lead OTHER

Principal Investigators

  • Carme Loras, MD · Hospital Universitari Mutua de Terrassa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2017-09-30
Completion
2018-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT02395354 on ClinicalTrials.gov