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Double-balloon Colonoscopy to Increase Cecal Intubation Rate in Technically Difficult Colonoscopies

18 Years
90 Years
Open (Enrolling)
Colorectal Cancer, Colorectal Adenomas, Inflammatory Bowel Disease

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Trial Information

Double-balloon Colonoscopy to Increase Cecal Intubation Rate in Technically Difficult Colonoscopies

This is a prospective cohort study to investigate the performance of the test instrument.
The test instrument consists of a slim, flexible colonoscope with an overtube and an
inflatable balloon on the tip of the colonoscope and the tip of the overtube. Patients are
eligible for inclusion if conventional colonoscopy fails due to technical difficulties such
as loop formation, long colonic segments or suspected adhesions. Written informed consent is
required. The study procedures will be performed immediately after the failed conventional
colonoscopy, or on a rescheduled appointment within four weeks.

Inclusion Criteria:

- Failed cecal intubation during conventional colonoscopy due to technical difficulties

Exclusion Criteria:

- Failed cecal intubation due to insufficient bowel preparation

- Stenotic colonic lesions

- Patients decline

- Pregnancy

- Persons younger than 18 years

- Persons unable to comprehend the information given

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Cecal intubation rate

Outcome Description:

The primary outcome measure is a complete or non-complete colonoscopy with the test instrument. Completion is assessed at the end of each procedure.

Outcome Time Frame:

2 hours

Safety Issue:


Principal Investigator

Michael Bretthauer, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cancer Registry of Norway, Oslo University Hospital


Norway: Regional Ethics Commitee

Study ID:




Start Date:

October 2011

Completion Date:

February 2014

Related Keywords:

  • Colorectal Cancer
  • Colorectal Adenomas
  • Inflammatory Bowel Disease
  • Colonoscopy
  • Colorectal cancer
  • Screening colonoscopy
  • Adenoma
  • Colorectal Neoplasms
  • Inflammatory Bowel Diseases
  • Intestinal Diseases