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Enteroscopy Stiffening Device for Retrograde Balloon Assisted Enteroscopy

NCT02275858 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2016-03-21

No results posted yet for this study

Summary

Balloon assisted enteroscopy has revolutionized the management of small bowel diseases by enabling endoscopic access deep into the small bowel. Using a combination of antegrade (through the mouth) and retrograde (through the anus) approaches, a large portion of the small bowel can be examined. Access to the proximal small bowel through the pylorus using the antegrade approach is straightforward but intubating the distal small bowel through the ileocecal valve is challenging due to the flexibility of the enteroscope. Recently, an enteroscopy stiffening wire has been developed. The purpose of our double blind placebo controlled randomized cross over study is to evaluate the performance of the enteroscopy stiffening wire in achieving terminal ileum intubation (TI) during retrograde balloon assisted enteroscopy.

Conditions

  • Small Bowel Diseases

Interventions

DEVICE

Stiffening wire

Stiffening wire

DEVICE

Placebo wire

Placebo wire

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Michael Sey, MD · London Health Sciences Centre-Victoria Campus

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Canada

Study Locations

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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 NCT02275858 on ClinicalTrials.gov