This trial is active, not recruiting.

Conditions colitis, adenoma, carcinoma, functional colonic disease
Treatments passive bending function, no passive bending function
Phase phase 2
Sponsor Norwegian Department of Health and Social Affairs
Collaborator Sykehuset Telemark
Start date August 2003
End date December 2007
Trial size 120 participants
Trial identifier NCT00518349, ST161006


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose diagnostic
(Active Comparator)
Colonoscopy using prototype colonoscope
passive bending function passive bending colonoscope
Colonoscope with a passive bending function
(Placebo Comparator)
Colonoscopy using standard colonoscope without a passive bending function
no passive bending function standard colonoscope Olympus CF-180AI
Examination using standard colonoscope without passive bending function

Primary Outcomes

Pain reduction during colonoscopy
time frame: Present phase evaluation in 2007

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients referred for routine outpatients colonoscopy Exclusion Criteria: - Pregnant women - Age below 18 years

Additional Information

Official title Evaluation of a Novel Colonoscope Designed for Easier Passage Through Flexures: A Randomised Study
Principal investigator Geir Hoff, MD, PhD
Description Results from the first prototype evaluation has been published.Modifications are presently evaluated.
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by Norwegian Department of Health and Social Affairs.