Image Transmission Applied to Organ Transplant: Before-af... | NCT03201224

Studies
Image Transmission Applied to Organ Transplant: Before-after Study of the Effectiveness of the Device

NCT03201224

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Apr 24, 2019Actual

Enrollment

20,000Estimated

Phase

Not provided

Conditions

Transplantation, Telemedicine

Interventions

"After" Group

Countries

France

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

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Jan 1, 2020Estimated

Completion Date

Mar 31, 2020Estimated

First Submitted Date

Jun 13, 2017

First Submission Date that Met QC Criteria

Jun 27, 2017

First Posted Date

Jun 28, 2017Actual

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

Apr 23, 2019

Last Update Posted Date

Apr 24, 2019Actual

Name	Class
Ministry of Health, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

In the complex process of organ transplant, two of the major steps are:

evaluation of the organs of potential donors in health institutions:
proposing grafts to the transplant teams, according to rules defined at the national level.

In the absence of the possibility of transmitting the images between the deceased donor sites and the transplant teams, the visualization of these examinations does not take part in the decision-making of the transplant team. This leads in the displacement of the transplant team in order to verify the grafts after acceptance of the graft proposal.

The "Cristal Image" project is a visualisation project for the transplant teams, in real time, at the time of the proposal of the graft so that they can give an opinion (acceptance, refusal) in less than 20 minutes (legal delay for a vital organ) after analyzing the medical records provided and the imaging data (scanner, ultrasound (s), coronary angiography, etc.).

The hypothesis of the project is that the implementation of a secure image transmission (complete anonymisation of the data of the donor) before the acceptance by the team, will allow an optimization of the use of the qualified organs by reducing risks, unnecessary displacement of transplant surgical teams, and securing the allocation of organs to recipient patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group without image transmission		"Before" Group
Group with image transmission		"After" Group	Device: "After" Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
"After" Group	Device		Group with image transmission

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of successful organ transplantation among those sampled.		3 months after transplantation for kidney, 1 year after transplantation for the other organs

Secondary Outcomes

Measure	Description	Time Frame
Number of assigned organs but not sampled		Immediately after the decision of the transplant team
Number of useless graft transportation		Immediately after the decision of the transplant team

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

French Donors who died in brain death, at least one organ of which was proposed for transplantation (kidneys, liver, heart, lung); Recipients transplanted during the same periods.

Exclusion Criteria:

Donors who died after cardiac arrest
Donors taken care in a foreign country or outside the Metropolitan France

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All health institutions authorized for organ transplantation in metropolitan France are concerned.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Isabelle Durand-Zaleski, MD, PhD	Contact			isabelle.durand-zaleski@aphp.fr

Overall Officials

Name	Affiliation	Role
Isabelle Durand-Zaleski, MD, PhD	Assistance Publique - Hôpitaux de Paris - DRCD URC Eco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Agence de la biomédecine	Recruiting	Saint-Denis		93200	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18764835	Background	Reddy MS, Bhati C, Neil D, Mirza DF, Manas DM. National Organ Retrieval Imaging System: results of the pilot study. Transpl Int. 2008 Nov;21(11):1036-44. doi: 10.1111/j.1432-2277.2008.00720.x.
25299785	Background	Rosenkrantz AB, Campbell N, Wehrli N, Triolo MJ, Kim S. New OPTN/UNOS classification system for nodules in cirrhotic livers detected with MR imaging: effect on hepatocellular carcinoma detection and transplantation allocation. Radiology. 2015 Feb;274(2):426-33. doi: 10.1148/radiol.14140069. Epub 2014 Oct 7.