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OpenTrials
Completed

NCT Number: NCT00518349

Colonoscope Passive Bending Function

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.

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Key information

Conditions

Colitis Adenoma Carcinoma Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Functional Colonic Disease Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gastroenterology section, Dept. of Medicine, Telemark Hospital

Skien, 3710, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients referred for routine outpatients colonoscopy

Exclusion criteria

  • Pregnant women
  • Age below 18 years

Treatment and study plan

Passive bending function

Device

Colonoscope with a passive bending function

Other names: passive bending colonoscope

No passive bending function

Device

Examination using standard colonoscope without passive bending function

Other names: standard colonoscope

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Norwegian Department of Health and Social Affairs

Other Gov

Collaborators

  • Sykehuset Telemark

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2009
First posted
Aug 20, 2007
Registry last updated
May 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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