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Gastro Intestinal Tele Endoscopy Project

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01924494
Collaborator
(none)
100
Enrollment
1
Location
12
Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Gastrointestinal Tele-Endoscopy Project: Synchronous Tele-Endoscopy - A Clinical Feasibility Study of Implementation of EndoAlpha Platform in Gastrointestinal Endoscopy.
    Study Start Date :
    Apr 1, 2012
    Actual Primary Completion Date :
    Apr 1, 2013
    Actual Study Completion Date :
    Apr 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Endoscopy procedures

    Patients undergoing elective flexible gastrointestinal endoscopy procedures

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate the potential network (LAN +WAN) limitations for video transmission image quality and audio transmission (two-way) quality. [1 year]

    Secondary Outcome Measures

    1. 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). [2 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Endoscopy Unit, Bispebjerg Hospiatl Copenhagen Denmark 2400

    Sponsors and Collaborators

    • Bispebjerg Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Soren Meisner, Consultant, Head of GI Endoscopy Unit, Bispebjerg Hospital
    ClinicalTrials.gov Identifier:
    NCT01924494
    Other Study ID Numbers:
    • GITEP
    First Posted:
    Aug 16, 2013
    Last Update Posted:
    Aug 16, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by Soren Meisner, Consultant, Head of GI Endoscopy Unit, Bispebjerg Hospital
    telemedicine, tele-endoscopy

    Study Results

    No Results Posted as of Aug 16, 2013