Colonoscopy Endoguide in Specialist Practice

NCT ID: NCT01055782

Last Updated: 2012-06-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1004 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-06-30

Brief Summary

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The study includes 700 patients referred for colonoscopy are randomized to colonoscopy with or without endoguide.

The study will investigate whether the endoguide improves success rate and the patient's perception of pain.

Detailed Description

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Conditions

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Colonoscopy Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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With endoguide

Colonoscopy completed with endoguide

Group Type EXPERIMENTAL

Endoguide

Intervention Type DEVICE

Use of endoguide to facilitate completion of endoscopy

Without endoguide

Colonoscopy completed without endoguide

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Endoguide

Use of endoguide to facilitate completion of endoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Informed consent provided

Exclusion Criteria

* Informed consent not provided or not possible to obtain
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Medical Association

OTHER

Sponsor Role collaborator

Surgical Clinic, Allerød, Denmark

UNKNOWN

Sponsor Role collaborator

The Specialist Doctors at Rolighedsvej

OTHER

Sponsor Role lead

Responsible Party

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Lene Hendel

MD, DMsc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Speciallægerne på Rolighedsvej

Birkerød, Birkerød, Denmark

Site Status

Countries

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Denmark

References

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Bak-Christensen A, Knudsen E, Hendel J, Ifaoui IB, Lehrskov-Schmidt L, Hendel L. Colonoscopy results are not enhanced by use of magnet endoguide in specialist practice. Dan Med J. 2013 Jun;60(6):A4611.

Reference Type DERIVED
PMID: 23743108 (View on PubMed)

Other Identifiers

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H-1-2009-80

Identifier Type: -

Identifier Source: org_study_id

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