Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial

Sorlandet Hospital HF

Status and phase: Completed; Phase 3

Conditions: Adenomas; Colorectal Cancer

Treatments: Device: Olympus PCF-Y0014-L; Device: Standard colonoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT01370928

PCF-Y0014-L

Details and patient eligibility

About

The purpose of this study is to compare the performance of a new prototype colonoscope with a standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with a smaller diameter than the standard colonoscope. The hypothesis to be tested is that the prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the patient. Both colonoscopes are manufactured by the same company.

Enrollment: 190 patients

Sex: All

Ages: 54 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Persons included in the NordICC trial are eligible for inclusion
• For information about the NordICC trial see clinicaltrials.gov NCT00883792

Exclusion criteria

• Pregnancy
• Persons younger than 18 years
• Persons unable to comprehend the information given
• not possible to start the examination without prior administration of sedation/analgesics

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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190 participants in 2 patient groups

Prototype colonoscope

Experimental group

Description:

The new colonoscope to be tested

Treatment:

Device: Olympus PCF-Y0014-L

Standard colonoscope

Active Comparator group

Description:

The standard colonoscope used world-wide today.

Treatment:

Device: Standard colonoscope