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Summary
This is a safety study designed to investigate the safety of utilizing the Kidney Protective Jacket (KPJ)™ during kidney transplantation. In general, we aim to use the device in all possible recipients, aiming to demonstrate its safety in the variable circumstances that may arise during kidney transplantation, e.g. single or multiple renal vessels, different-sized kidneys, and variable recipient size and weight.
Official title: The Effect of Intraoperative Thermal Kidney Insulation on Current Kidney Transplantation Surgical Practices
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-03-01
Completion Date
2026-12-31
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
Kidney Protective Jacket
The KPJ™ is a novel thermal insulating protective jacket specifically designed to be applied to the kidney during transplant anastomoses, or the SWIT interval. It is applied prior to removing the kidney from cold storage, and remains on for the duration of anastomoses, after which it can be easily removed. The Kidney Protective Jacket (KPJ) was designed and developed in accordance with ISO 13485 and 21 CFR 820 design control requirements. Throughout the development process, relevant standards were applied, including those related to risk management (ISO 14971), usability engineering (IEC 62366), biocompatibility of materials (ISO 10993 series), and sterilisation validation (ISO 11137). Manufacturing is carried out by an ISO 13485-certified contract manufacturer, with processes including injection moulding of medical-grade silicone, assembly of the sterile barrier system (comprising a medical-grade plastic tray and Tyvek® seal), and final device packaging. Sterilisation is performed us
Locations (1)
Westmead Hospital
Westmead, New South Wales, Australia