- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01055782
Colonoscopy Endoguide in Specialist Practice
June 6, 2012 updated by: Lene Hendel, The Specialist Doctors at Rolighedsvej
Kan Anvendelse af Endoskopisk Positioneringsudstyr Ved coloskopiundersøgelsen (kikkertundersøgelse af Tarmen) i en højt Specialiseret Praksis Forbedre Patientens Subjektive Kvalitetsoplevelse (Smerteperception)?
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
1004
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Birkerød, Denmark, 3460
- Speciallægerne på Rolighedsvej
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Informed consent provided
Exclusion Criteria:
- Informed consent not provided or not possible to obtain
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: With endoguide
Colonoscopy completed with endoguide
|
Use of endoguide to facilitate completion of endoscopy
|
No Intervention: Without endoguide
Colonoscopy completed without endoguide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Completed Colonoscopy
Time Frame: immediately after colonoscopy
|
immediately after colonoscopy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perception of Pain
Time Frame: After endoscopy (within 10mins) and 1 day after endoscopy
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
January 24, 2010
First Submitted That Met QC Criteria
January 25, 2010
First Posted (Estimate)
January 26, 2010
Study Record Updates
Last Update Posted (Estimate)
June 11, 2012
Last Update Submitted That Met QC Criteria
June 6, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H-1-2009-80
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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