Colonoscope Passive Bending Function

September 15, 2017 updated by: Geir Hoff, Norwegian Department of Health and Social Affairs

Evaluation of a Novel Colonoscope Designed for Easier Passage Through Flexures: A Randomised Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Skien, Norway, 3710
        • Gastroenterology section, Dept. of Medicine, Telemark Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients referred for routine outpatients colonoscopy

Exclusion Criteria:

  • Pregnant women
  • Age below 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • standard colonoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Pain experienced during colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian Department of Health and Social Affairs

Collaborators

Sykehuset Telemark

Investigators

  • Principal Investigator: Geir Hoff, MD, PhD, Head of Research, Telemark Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

August 17, 2007

First Submitted That Met QC Criteria

August 17, 2007

First Posted (Estimate)

August 20, 2007

Study Record Updates

Last Update Posted (Actual)

May 29, 2018

Last Update Submitted That Met QC Criteria

September 15, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST161006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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