Prospective, Single-Arm, Study to Assess the Safety and Performance of the TB1-K Device for Organ Preservation in Donor Kidneys for Transplantation (EMERGE)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03600285|
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
TB1-K Device is an organ preservation and transportation system, using ultrasound technology with a cooling system to preserve the organ in optimal conditions during transport to the transplant recipient.
This is a prospective, single-arm, multi-center study comparing to a historical control for cold storage.
The study is conducted in accordance with the Standard ISO 14155 (Clinical investigation of medical devices for human subjects - Good clinical practice), and other legal requirements.
The study objective is to assess the safety and performance of the TB1-K device in donor kidneys intended for transplantation.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Preservation and Transportation||Device: TB1-K||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Single-Arm, Study to Assess the Safety and Performance of the TB1-K Device for Organ Preservation in Donor Kidneys for Transplantation|
|Actual Study Start Date :||June 29, 2018|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||May 31, 2020|
- Device: TB1-K
Use of TB1-K for preservation and transport of donated kidneys
- Rate of DGF [ Time Frame: 1 week after transplant ]Rate of delayed graft function (DGF), defined as need for dialysis in the first week after transplant, once hyperacute rejection, vascular and urinary tract complications are ruled out.
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): NCT03600285
|Contact: Diana Villanueva, MSc||+34 93 527 27 20 ext email@example.com|
|Hospital Unviersitario de Bellvitge||Recruiting|
|Barcelona, Hospitalet De Llobregat, Spain, 08907|
|Contact: Salvador Gil-Vernet, PhD +34 93 260 76 98 firstname.lastname@example.org|
|Hospital Universitario Vall d'Hebron||Recruiting|
|Barcelona, Spain, 08035|
|Contact: Daniel Seron, PhD +34 93 274 62 19 email@example.com|
|Hospital Clinic i Provincial de Barcelona||Recruiting|
|Barcelona, Spain, 08036|
|Contact: Fritz Diekmann, PhD +34 93 227 54 44 firstname.lastname@example.org|
|Principal Investigator:||Fritz Diekmann, PhD||Hospital Clinic i provincial de Barcelona|