Colonoscopy Screening Using a Novel Slim Colonoscope

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Cancer Adenomas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Prototype colonoscope

The new colonoscope to be tested

Group Type EXPERIMENTAL

Olympus PCF-Y0014-L

Intervention Type DEVICE

Screening colonoscopy with a prototype colonoscope

Standard colonoscope

The standard colonoscope used world-wide today.

Group Type ACTIVE_COMPARATOR

Standard colonoscope

Intervention Type DEVICE

Screening colonoscopy

Interventions

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Olympus PCF-Y0014-L

Screening colonoscopy with a prototype colonoscope

Intervention Type DEVICE

Standard colonoscope

Screening colonoscopy

Intervention Type DEVICE

Other Intervention Names

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Olympus PCF-Y0014-L colonoscope Olympus series 160 colonoscope

Eligibility Criteria

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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

Minimum Eligible Age

54 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes