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Colonoscope Passive Bending Function

Primary Purpose

Colitis, Adenoma, Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Passive bending function
No passive bending function
Sponsored by
Norwegian Department of Health and Social Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients referred for routine outpatients colonoscopy

Exclusion Criteria:

  • Pregnant women
  • Age below 18 years

Sites / Locations

  • Gastroenterology section, Dept. of Medicine, Telemark Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Prototype colonoscope

Standard colonoscope

Arm Description

Colonoscopy using prototype colonoscope with passive bending function

Colonoscopy using standard colonoscope with no passive bending function

Outcomes

Primary Outcome Measures

Patient Assessment of 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).

Secondary Outcome Measures

Full Information

First Posted
August 17, 2007
Last Updated
September 15, 2017
Sponsor
Norwegian Department of Health and Social Affairs
Collaborators
Sykehuset Telemark
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1. Study Identification

Unique Protocol Identification Number
NCT00518349
Brief Title
Colonoscope Passive Bending Function
Official Title
Evaluation of a Novel Colonoscope Designed for Easier Passage Through Flexures: A Randomised Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norwegian Department of Health and Social Affairs
Collaborators
Sykehuset Telemark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Adenoma, Carcinoma, Functional Colonic Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prototype colonoscope
Arm Type
Active Comparator
Arm Description
Colonoscopy using prototype colonoscope with passive bending function
Arm Title
Standard colonoscope
Arm Type
Placebo Comparator
Arm Description
Colonoscopy using standard colonoscope with no passive bending function
Intervention Type
Device
Intervention Name(s)
Passive bending function
Other Intervention Name(s)
passive bending colonoscope
Intervention Description
Colonoscope with a passive bending function
Intervention Type
Device
Intervention Name(s)
No passive bending function
Other Intervention Name(s)
standard colonoscope
Intervention Description
Examination using standard colonoscope without passive bending function
Primary Outcome Measure Information:
Title
Patient Assessment of Pain Experienced During Colonoscopy
Description
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).
Time Frame
Pain experienced during colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients referred for routine outpatients colonoscopy Exclusion Criteria: Pregnant women Age below 18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geir Hoff, MD, PhD
Organizational Affiliation
Head of Research, Telemark Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterology section, Dept. of Medicine, Telemark Hospital
City
Skien
ZIP/Postal Code
3710
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
20923378
Citation
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.
Results Reference
background
PubMed Identifier
16281143
Citation
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.
Results Reference
result

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Colonoscope Passive Bending Function

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