Colonoscope Passive Bending Function

NCT00518349 | Completed Results

• 1 other identifier: ST161006
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Colitis; Adenoma; Carcinoma; Functional Colonic Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Prototype colonoscope

ACTIVE COMPARATOR

Colonoscopy using prototype colonoscope with passive bending function

Device: Passive bending function

Standard colonoscope

PLACEBO COMPARATOR

Colonoscopy using standard colonoscope with no passive bending function

Device: No passive bending function

Interventions

Passive bending function DEVICE

Colonoscope with a passive bending function

Also known as: passive bending colonoscope

Prototype colonoscope

No passive bending function DEVICE

Examination using standard colonoscope without passive bending function

Also known as: standard colonoscope

Standard colonoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for routine outpatients colonoscopy

You may not qualify if:

• Pregnant women
• Age below 18 years

Sponsors & Collaborators

• Norwegian Department of Health and Social Affairs: lead
• Sykehuset Telemark: collaborator

Study Sites (1)

Gastroenterology section, Dept. of Medicine, Telemark Hospital

Skien, 3710, Norway

Location

Related Publications (2)

• 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.

  PMID: 20923378 BACKGROUND

• 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.

  PMID: 16281143 RESULT

MeSH Terms

Conditions

Colitis; Adenoma; Carcinoma; Colonic Diseases, Functional

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Dr. Geir Hoff
• Organization: NorwegianDohsa

hofg@online.no

+4791866762

Study Officials

• Geir Hoff, MD, PhD

  Head of Research, Telemark Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research, Telemark Hospital

Study Record Dates

• First Submitted: August 17, 2007
• First Posted: August 20, 2007
• Study Start: August 1, 2003
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2009
• Last Updated: May 29, 2018
• Results First Posted: May 29, 2018

Record last verified: 2017-09

Locations

NO (1)