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

A

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

Transplantation, Telemedicine

Treatments

Device: "After" Group

Study type

Observational

Funder types

Other

Identifiers

NCT03201224
PREPS - Cristal Images

Details and patient eligibility

About

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

  1. evaluation of the organs of potential donors in health institutions:
  2. 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.

Enrollment

20,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

20,000 participants in 2 patient groups

Group without image transmission
Description:
"Before" Group
Group with image transmission
Description:
"After" Group
Treatment:
Device: "After" Group

Trial contacts and locations

1

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Central trial contact

Isabelle Durand-Zaleski, MD, PhD

Data sourced from clinicaltrials.gov

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