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Double-balloon Colonoscopy to Increase Colonoscopy Completion Rate

NCT01587872 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2014-04-14

No results posted yet for this study

Summary

The aim of colonoscopy is to visualize the inside of the entire large bowel. Several factors can make the procedure difficult, and sometimes a complete examination is not possible. Complicating factors include poor bowel preparation and technical challenges such as differences in anatomy (long, redundant colonic segments), post-surgical adhesions, strictures and diverticulosis. A special endoscope with two inflatable balloons, originally designed to examine the small bowel, has been used for several years with success in such technically difficult colonoscopies. More recently a modified double-balloon instrument was designed specifically for colonoscopy, but the documentation of the performance of this instrument is limited. The aim of the present study is to investigate the performance of the double-balloon colonoscope in cases where conventional colonoscopy have failed due to technical difficulties.

Conditions

Interventions

PROCEDURE

Fujinon EC-450BI5 double-balloon colonoscope

Colonoscopy with the test instrument

Sponsors & Collaborators

  • South-Eastern Norway Regional Health Authority

    collaborator OTHER

  • Fujifilm Europa

    collaborator UNKNOWN

  • Sorlandet Hospital HF

    lead OTHER_GOV

Principal Investigators

  • Michael Bretthauer, PhD · The Cancer Registry of Norway, Oslo University Hospital

  • Kjetil K Garborg, MD · Sorlandet Hospital HF, Kristiansand, Norway

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Norway

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 NCT01587872 on ClinicalTrials.gov