Colonoscope Passive Bending Function

Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518349
• Other study ID #: ST161006
• Status: Completed
• Phase: N/A
• Start date: August 2003
• Est. completion date: December 2009

Study information

• Verified date: September 2017
• Source: Norwegian Department of Health and Social Affairs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients referred for routine outpatients colonoscopy

Exclusion Criteria:

• Pregnant women

• Age below 18 years

Related Conditions & MeSH terms

• Adenoma
• Carcinoma
• Colitis
• Colonic Diseases
• Colonic Diseases, Functional
• Functional Colonic Disease

Intervention

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

Locations

Country	Name	City	State
Norway	Gastroenterology section, Dept. of Medicine, Telemark Hospital	Skien

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian Department of Health and Social Affairs	Sykehuset Telemark

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Hoff G, Bretthauer M, Huppertz-Hauss G, Sauar J, Paulsen J, Dahler S, Kjellevold Ø. Evaluation of a novel colonoscope designed for easier passage through flexures: a randomized study. Endoscopy. 2005 Nov;37(11):1123-6. — View Citation

Hoff G, Moritz V, Bretthauer M, Ludolph T, Huppertz-Hauss G, Paulsen J, Seip B, Sauar J, Kjellevold Ø, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Pain experienced during colonoscopy