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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
Sponsor:
Collaborator:
Sykehuset Telemark
Information provided by:
Norwegian Department of Health and Social Affairs
ClinicalTrials.gov Identifier:
NCT00518349
First received: August 17, 2007
Last updated: March 19, 2009
Last verified: March 2009
History of Changes
  Purpose

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
Colitis
Adenoma
Carcinoma
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:

U.S. FDA Resources

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.

  Eligibility

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

Inclusion Criteria:

  • Patients referred for routine outpatients colonoscopy

Exclusion Criteria:

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

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor Geir Hoff, Head of Hospital Research, Telemark Hospital
ClinicalTrials.gov 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:
Adenoma
Carcinoma
Colitis
Colonic Diseases
Colonic Diseases, Functional
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on June 13, 2013