Kidney Protective Jacket
ConditionKidney Transplant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsoriiShield
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Paediatric donor kidneys (kidneys from donors < 16 years in age)
Patients with a known allergy or hypersensitivity to silicone
Trial design
Design model
Single group
Treatments tested in this trial
Kidney Protective Jacket
DeviceThe 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
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Kidney Protective JacketExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of the Kidney Protective Jacket
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.
Time frame
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.Secondary outcomes
1
Device related events
Non-serious adverse device effects (n) and Non-device-related adverse events (n)
Time frame
When 20 participants have been recruited and 30 days post transplantation procedure.2
Temperature change during SWIT (°C)
Temperature change during SWIT (°C)
Time frame
When 20 participants have been recruited and 30 days post transplantation procedure.3
Surgery time (minutes)
Surgery time (minutes)
Time frame
When 20 participants have been recruited and 30 days post transplantation procedure.4
Delayed graft function (%)
Delayed graft function (%)
Time frame
When 20 participants have been recruited and 30 days post transplantation procedure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
iiShield
Lead sponsor
Western Sydney Local Health District
Collaborator
Source ClinicalTrials.gov