Kidney Protective Jacket
The Effect of Intraoperative Thermal Kidney Insulation on Current Kidney Transplantation Surgical Practices
iiShield
20 participants
Mar 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- All deceased and living donor kidneys that are deemed suitable for transplantation
- All suitable recipients who are 18 years or greater, and undergoing their first or second kidney transplant
- All recipients must be able to provide full informed consent
Exclusion Criteria2
- Paediatric donor kidneys (kidneys from donors \< 16 years in age)
- Patients with a known allergy or hypersensitivity to silicone
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Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07348458