Colonoscope Passive Bending Function

Norwegian Department of Health and Social Affairs

Status: Completed

Conditions: Functional Colonic Disease; Carcinoma; Colitis; Adenoma

Treatments: Device: Passive bending function; Device: No passive bending function

Study type: Interventional

Funder types: Other

Identifiers

NCT00518349

ST161006

Details and patient eligibility

About

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.

Full description

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

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients referred for routine outpatients colonoscopy

Exclusion criteria

• Pregnant women
• Age below 18 years

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups, including a placebo group

Prototype colonoscope

Active Comparator group

Description:

Colonoscopy using prototype colonoscope with passive bending function

Treatment:

Device: Passive bending function

Standard colonoscope

Placebo Comparator group

Description:

Colonoscopy using standard colonoscope with no passive bending function

Treatment:

Device: No passive bending function