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
Qualifiers
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
Treatments tested in this trial
- Kidney Protective Jacket
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
iiShield
Lead sponsor
Western Sydney Local Health District
Collaborator
Source ClinicalTrials.gov