Colonoscope Passive Bending Function

Overview

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.

Full Title of Study: “Evaluation of a Novel Colonoscope Designed for Easier Passage Through Flexures: A Randomised Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2007

Detailed Description

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

Interventions

  • Device: Passive bending function
    • Colonoscope with a passive bending function
  • Device: No passive bending function
    • Examination using standard colonoscope without passive bending function

Arms, Groups and Cohorts

  • Active Comparator: Prototype colonoscope
    • Colonoscopy using prototype colonoscope with passive bending function
  • Placebo Comparator: Standard colonoscope
    • Colonoscopy using standard colonoscope with no passive bending function

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Participating in This Clinical Trial

Inclusion Criteria

  • Patients referred for routine outpatients colonoscopy Exclusion Criteria:

  • Pregnant women – Age below 18 years

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Norwegian Department of Health and Social Affairs
  • Collaborator
    • Sykehuset Telemark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Geir Hoff, Head of Research, Telemark Hospital – Norwegian Department of Health and Social Affairs
  • Overall Official(s)
    • Geir Hoff, MD, PhD, Principal Investigator, Head of Research, Telemark Hospital

References

Hoff G, Moritz V, Bretthauer M, Ludolph T, Huppertz-Hauss G, Paulsen J, Seip B, Sauar J, Kjellevold O, Chengarov L. Colonoscope with a sub-distal hyper-flaccid segment for improved insertion at colonoscopy: a randomized study. Scand J Gastroenterol. 2011 Jan;46(1):104-8. doi: 10.3109/00365521.2010.521891. Epub 2010 Oct 6.

Citations Reporting on Results

Hoff G, Bretthauer M, Huppertz-Hauss G, Sauar J, Paulsen J, Dahler S, Kjellevold O. Evaluation of a novel colonoscope designed for easier passage through flexures: a randomized study. Endoscopy. 2005 Nov;37(11):1123-6. doi: 10.1055/s-2005-870444.

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