New Phototherapy Device to Treat Patients With Crigler-Najjar Disease (DRAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02356978|
Recruitment Status : Unknown
Verified December 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : February 6, 2015
Last Update Posted : September 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Crigler Najjar Syndrome Children||Device: Arm1 homemade phototherapy treatment Device: DRAP||Not Applicable|
Crigler-Najjar (CN) syndrome is a congenital inborn error of hepatic bilirubin metabolism caused by the deficiency of bilirubin uridinediphosphate glucuronosyltransferase activity CN patients are at permanent risk of life-threatening bilirubin encephalopathy (kernicterus). Treatment of CN disease relies on daily prolonged phototherapy (10-12 h/day). To date, liver transplantation is the only curative treatment available. To date, no phototherapy device exists for teenagers and adults. CN patients use homemade systems or add several neonatal systems together to reach a better efficacy.
A new device has been designed by weaving optical fibers into a sheet connected to LEDs. This new technology, marketed by several manufacturers of phototherapy devices, is used in pediatric wards for treating jaundiced newborns. A prototype of 80× 100cm was thus developed, which combines numerous advantages : important surface of treatment, easy use and transportation, user-friendliness.
Before going to a therapeutic trial for assessing the benefits of this new device in ambulatory current practice, it is essential to make sure of both its feasibility and efficiency on the control of bilirubinemia, under medical supervision.
Hypothesis: the new phototherapy sheet is as effective as, and better tolerated than the usual devices used in CN patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trial of a New Phototherapy Device for Treating Hyperbilirubinemia in Crigler-Najjar Patients : a New Concept|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Arm 1
Each patient will be treated before using the active usual homemade device, and after using the experimental new "DRAP" device.
This new sheet was designed by weaving optical fibers connected to LEDs ( "BROCHIER" Technology). The "LIGHTEX" technology ® is a principle of weaving mill of optical fibres with side lighting connected to LEDs and allowing to realize flexible or stiff bright surfaces with very weak congestions, low consumption and high life cycle. The energy illumination of this device varies between 3 and 4 mW / cm ² ( average 3,6 mW / cm ².)
Device: Arm1 homemade phototherapy treatment
session of 10 or 12 hours phototherapy treatment using the homemade device during the first night and then the "DRAP" device during the next nights.
- Kinetic of blood Bilirubin level using the "DRAP" device (blood bilirubin concentration) [ Time Frame: Before using "DRAP" device (H0), and after using (Hour12, Hour 36, Hour 48, Hour 60, Hour 72, Hour 84, Hour 96) ]blood bilirubin concentration will be measured 2 times during phototherapy treatment (before and after phototherapy)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356978
|Contact: VINCENT GAJDOS, Professor||+33 1 45 37 42 firstname.lastname@example.org|
|AP-HP, Antoine Béclère Hospital||Recruiting|
|Clamart, France, 92141|
|Contact: VINCENT GAJDOS, Professor +33 1 45 37 42 72 email@example.com|
|Principal Investigator:||VINCENT GAJDOS, Professor||AP-HP, Antoine Béclère Hospital|