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Colonoscope Passive Bending Function

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Norwegian Department of Health and Social Affairs.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00518349
First Posted: August 20, 2007
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sykehuset Telemark
Information provided by:
Norwegian Department of Health and Social Affairs
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Evaluation of a Novel Colonoscope Designed for Easier Passage Through Flexures: A Randomised Study

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients referred for routine outpatients colonoscopy

Exclusion Criteria:

  • Pregnant women
  • Age below 18 years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: August 17, 2007
First Posted: August 20, 2007
Last Update Posted: October 12, 2017
Last Verified: March 2009

Additional relevant MeSH terms:
Adenoma
Colonic Diseases
Colonic Diseases, Functional
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases