Gastro Intestinal Tele Endoscopy Project | NCT01924494

Studies
Gastro Intestinal Tele Endoscopy Project

NCT01924494

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

Aug 16, 2013Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Aug 16, 2012

First Submission Date that Met QC Criteria

Aug 15, 2013

First Posted Date

Aug 16, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2013

Last Update Posted Date

Aug 16, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endoscopy procedures		Patients undergoing elective flexible gastrointestinal endoscopy procedures

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the potential network (LAN +WAN) limitations for video transmission image quality and audio transmission (two-way) quality.		1 year

Secondary Outcomes

Measure	Description	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).		2 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing elective gastrointestinal endoscopy procedures

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Endoscopy Unit, Bispebjerg Hospiatl		Copenhagen		2400	Denmark