Kidney Protective Jacket

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• Safety of the Kidney Protective Jacket — Until 20 participants are recruited, baseline participant characteristics collected pre-operatively, intra-operative times noted, and incidence of serious adverse events at 30 days post procedure.
  The primary objective is to assess the safety of use of KPJ™ (per its intended use) during kidney transplantation. Specifically, we are assessing the proportion of participants sustaining Serious Adverse Effects directly attributable to KPJ use (i.e., Serious Adverse Device Events \[SADE\]) in the time period of 30 days post transplantation. We also want to examine the safety in variable circumstances, e.g. single and multiple renal vessels, different sized kidneys, variable recipient size and weights.

Trial sites (1)

Other trials for the same condition