Improving Quality of Colonoscopy Using a 3D-imager

NCT ID: NCT00519129

Last Updated: 2011-08-18

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

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-08-31

Brief Summary

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Coloscopy may be a painful procedure for the patient. This is due to a loop-formation of the coloscope. A 3D-real time imager produced by Olympus creates a real-time image of the scope while a traditional fluoroscopy device will only show instant pictures. We want to investigate whether the 3D-imager causes the patient less pain and is more time consuming than ordinary fluoroscopy

Detailed Description

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Results published in Holme et.al. Gastrointestinal Endoscopy 2011;73:1215-1222.

Conditions

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Pain During Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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3D-imager

3D-imager vs fluoroscopy during coloscopy

Intervention Type DEVICE

Other Intervention Names

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Skopguide

Eligibility Criteria

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Inclusion Criteria

* All patients referred for coloscopy on an out-patient basis

Exclusion Criteria

* Pregnancy
* Pacemaker
* Lack of ability to understand information given
* Prior resection of the colon/rectum
* Demanding analgetics prior to start of procedure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sorlandet Hospital HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sorlandet Hospital HF

Principal Investigators

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Geir S Hoff, PhD

Role: STUDY_DIRECTOR

Locations

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Sorlandet Sykehus HF

Kristiansand, , Norway

Site Status

Countries

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Norway

References

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Holme O, Hoie O, Matre J, Stallemo A, Garborg K, Hasund A, Wiig H, Hoff G, Bretthauer M. Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: a randomized, controlled trial. Gastrointest Endosc. 2011 Jun;73(6):1215-22. doi: 10.1016/j.gie.2011.01.054. Epub 2011 Apr 8.

Reference Type DERIVED
PMID: 21481862 (View on PubMed)

Other Identifiers

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SSHF-Colon-1

Identifier Type: -

Identifier Source: org_study_id

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