Gastro Intestinal Tele Endoscopy Project

Evaluate System Integration of EndoAlpha Clinical Trial

Official title:

Gastrointestinal Tele-Endoscopy Project: Synchronous Tele-Endoscopy - A Clinical Feasibility Study of Implementation of EndoAlpha Platform in Gastrointestinal Endoscopy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924494
• Other study ID #: GITEP
• Status: Completed
• Phase: N/A
• First received: August 16, 2012
• Last updated: August 15, 2013
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: August 2013
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Evaluate System Integration of EndoAlpha
• Investigate the Potential Network Limitations
• Validate the Technology for Later Clinical Use

Locations

Country	Name	City	State
Denmark	Endoscopy Unit, Bispebjerg Hospiatl	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the potential network (LAN +WAN) limitations for video transmission image quality and audio transmission (two-way) quality.		1 year	No
Secondary	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	No