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NCT01055782 Clinical Trial

Colonoscopy Endoguide in Specialist Practice

Pain Clinical Trial

Official title:
Kan Anvendelse af Endoskopisk Positioneringsudstyr Ved coloskopiundersøgelsen (kikkertundersøgelse af Tarmen) i en højt Specialiseret Praksis Forbedre Patientens Subjektive Kvalitetsoplevelse (Smerteperception)?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01055782
Other study ID # H-1-2009-80
Secondary ID
Status Completed
Phase N/A
First received January 24, 2010
Last updated June 6, 2012
Start date November 2009
Est. completion date June 2012

Study information
Verified date June 2012
Source The Specialist Doctors at Rolighedsvej
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 1004
Est. completion date June 2012
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Informed consent provided

Exclusion Criteria:

- Informed consent not provided or not possible to obtain

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• Endoguide
Use of endoguide to facilitate completion of endoscopy

Locations
Country Name City State
Denmark Speciallægerne på Rolighedsvej Birkerød

Sponsors (3)
Lead Sponsor Collaborator
The Specialist Doctors at Rolighedsvej Danish Medical Association, Surgical Clinic, Allerød, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Completed Colonoscopy immediately after colonoscopy No
Secondary Perception of Pain VAS (Visual Analogue Scale), 0 - 10. VAS 0 is no pain, VAS 10 is max pain. Scores on a scale After endoscopy (within 10mins) and 1 day after endoscopy No
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