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ACTIVE NOT RECRUITING
NCT05112315
NA

Clinical Impact of the IBox As an Early Intervention TooL

Sponsor: Predict4Health

View on ClinicalTrials.gov

Summary

International, multicentre, randomized 1:1 controlled trial to prove the clinical and medico economic benefits of the medical device Predigraft, by showing that the use of Predigraft could improve patient's follow-up.

Official title: Clinical Impact of the IBox As an Early Intervention TooL: a Prospective Randomised Controlled Trial to Assess the Use of a Software Predicting Allograft Survival in the Follow-up of Kidney Transplanted Patients.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

507

Start Date

2022-02-18

Completion Date

2025-02

Last Updated

2024-10-04

Healthy Volunteers

No

Interventions

DEVICE

Predigraft

The Subject randomized to the Predigraft will benefit from Predigraft, a remote monitoring software that issues an alert to the investigator when the allograft survival prediction calculated by the iBox algorithm is decreasing. This follow-up is on top of the site's standard of care.

Locations (16)

Medizinische Universität Innsbruck

Innsbruck, Austria

Hôpital Saint-Louis

Paris, France, France

Hôpital Tenon

Paris, France, France

CHU Rangueil

Toulouse, France, France

Hôpital Necker

Paris, France

Universitätsklinikum Düsseldorf AÖR

Düsseldorf, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Sourasky Medical Center - Ichilov Hospital

Tel Aviv, Israel

Hospital Del Mar - Parc de Salut Mar

Barcelona, Spain

Fundació Puigvert

Barcelona, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Spain

Queen Elizabeth Hospital

Birmingham, United Kingdom

Leeds Teaching Hospital NHS Trust

Leeds, United Kingdom

Guy's & Saint Thomas' NHS Foundation Trust

London, United Kingdom

King's College Hospital

London, United Kingdom

Oxford Transplant Centre

Oxford, United Kingdom