ClinicalTrials.gov
ClinicalTrials.gov Menu

Colonoscope Passive Bending Function

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.
ClinicalTrials.gov Identifier: NCT00518349
Recruitment Status : Completed
First Posted : August 20, 2007
Results First Posted : May 28, 2018
Last Update Posted : May 28, 2018
Sponsor:
Collaborator:
Sykehuset Telemark
Information provided by (Responsible Party):
Geir Hoff, Norwegian Department of Health and Social Affairs

Brief Summary:
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 or disease Intervention/treatment Phase
Colitis Adenoma Carcinoma Functional Colonic Disease Device: Passive bending function Device: No passive bending function Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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
Study Start Date : August 2003
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Active Comparator: Prototype colonoscope
Colonoscopy using prototype colonoscope with passive bending function
Device: Passive bending function
Colonoscope with a passive bending function
Other Name: passive bending colonoscope

Placebo Comparator: Standard colonoscope
Colonoscopy using standard colonoscope with no passive bending function
Device: No passive bending function
Examination using standard colonoscope without passive bending function
Other Name: standard colonoscope




Primary Outcome Measures :
  1. Patient Assessment of Pain Experienced During Colonoscopy [ Time Frame: Pain experienced during colonoscopy ]
    The proportion of patients reporting "no pain" when examined with prototype or standard colonoscope, respectively. Pain experienced was assessed by the patient in a questionnaire to be filled in at home on the day after the examination and mailed in a pre-paid envelope to a national quality register (Gastronet).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Publications of Results:
Other Publications:
Responsible Party: Geir Hoff, Head of Research, Telemark Hospital, Norwegian Department of Health and Social Affairs
ClinicalTrials.gov Identifier: NCT00518349     History of Changes
Other Study ID Numbers: ST161006
First Posted: August 20, 2007    Key Record Dates
Results First Posted: May 28, 2018
Last Update Posted: May 28, 2018
Last Verified: September 2017

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