- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01924494
Gastro Intestinal Tele Endoscopy Project
August 15, 2013 updated by: Soren Meisner, Bispebjerg Hospital
Gastrointestinal Tele-Endoscopy Project: Synchronous Tele-Endoscopy - A Clinical Feasibility Study of Implementation of EndoAlpha Platform in Gastrointestinal Endoscopy.
Synchronous Tele-Endoscopy: A clinical feasibility study of gastrointestinal tele-endoscopy by implementing and evaluating synchronous tele-endoscopy using ENDOALPHA in a hospital based endoscopy unit.
EndoAlpha will be used on the hospitals existing Intranet/LAN and the possibilities of tele-endoscopy on WAN through existing network, on separate dedicated line or through new established transmission lines, will be evaluated.
The EndoAlpha system will be integrated in a highly advanced endoscopy procedure room.
The system will integrate through LAN with doctor office, clinic conference and lecture room and GI pathologist room.
Through either LAN or WAN, connection will be establish to a referral GI center in Denmark.
Through WAN, connection will be established to doctor home and to an expert Spanish center.
Study Overview
Status
Completed
Detailed Description
Evaluate the potential network (LAN +WAN) limitations for video transmission image quality and audio transmission (two-way) quality.
Validate the tele-endoscopy technology for consulting and second opinion in diagnostic endoscopy and therapeutic endoscopy (teaching, training and supervision of basic and advanced therapeutic procedures).
Study Type
Observational
Enrollment (Actual)
100
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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Copenhagen, Denmark, 2400
- Endoscopy Unit, Bispebjerg Hospiatl
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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 to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing elective gastrointestinal endoscopy procedures
Description
Inclusion Criteria:
- Patients scheduled for elective gastrointestinal endoscopic procedures
Exclusion Criteria:
- Age < 18 years or > 90 years
- Unwilling to participate (no informed consent)
- Not able to understand and read Danish
- Emergency endoscopic procedures
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
Cohorts and Interventions
Group / Cohort |
|---|
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Endoscopy procedures
Patients undergoing elective flexible gastrointestinal endoscopy procedures
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluate the potential network (LAN +WAN) limitations for video transmission image quality and audio transmission (two-way) quality.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Validate the tele-endoscopy technology for consulting and second opinion in diagnostic endoscopy and therapeutic endoscopy (teaching, training and supervision of basic and advanced therapeutic procedures).
Time Frame: 2 year
|
2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
April 1, 2012
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
August 16, 2012
First Submitted That Met QC Criteria
August 15, 2013
First Posted (Estimate)
August 16, 2013
Study Record Updates
Last Update Posted (Estimate)
August 16, 2013
Last Update Submitted That Met QC Criteria
August 15, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GITEP
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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