Colonoscope Passive Bending Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Norwegian Department of Health and Social Affairs.
Recruitment status was  Active, not recruiting
Sykehuset Telemark
Information provided by:
Norwegian Department of Health and Social Affairs Identifier:
First received: August 17, 2007
Last updated: March 19, 2009
Last verified: March 2009

A prototype colonoscope with an extra passively bending distal section has been developed by Olympus Japan (ref. publications). The present study (2006-2007) is testing refinements of this function.

Condition Intervention Phase
Functional Colonic Disease
Device: Passive bending function
Device: No passive bending function
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Evaluation of a Novel Colonoscope Designed for Easier Passage Through Flexures: A Randomised Study

Resource links provided by NLM:

Further study details as provided by Norwegian Department of Health and Social Affairs:

Primary Outcome Measures:
  • Pain reduction during colonoscopy [ Time Frame: Present phase evaluation in 2007 ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: August 2003
Estimated Study Completion Date: December 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Colonoscopy using prototype colonoscope
Device: Passive bending function
Colonoscope with a passive bending function
Other Name: passive bending colonoscope
Placebo Comparator: 2
Colonoscopy using standard colonoscope without a passive bending function
Device: No passive bending function
Examination using standard colonoscope without passive bending function
Other Name: standard colonoscope Olympus CF-180AI

Detailed Description:

Results from the first prototype evaluation has been published.Modifications are presently evaluated.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients referred for routine outpatients colonoscopy

Exclusion Criteria:

  • Pregnant women
  • Age below 18 years
  Contacts and Locations
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Please refer to this study by its identifier: NCT00518349

Gastroenterology section, Dept. of Medicine, Telemark Hospital
Skien, Norway, 3710
Sponsors and Collaborators
Norwegian Department of Health and Social Affairs
Sykehuset Telemark
Principal Investigator: Geir Hoff, MD, PhD Head of Research, Telemark Hospital
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Professor Geir Hoff, Head of Hospital Research, Telemark Hospital Identifier: NCT00518349     History of Changes
Other Study ID Numbers: ST161006
Study First Received: August 17, 2007
Last Updated: March 19, 2009
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases processed this record on October 02, 2015