Kidney Protective Jacket to keep donated kidneys cool during transplant
The Effect of Intraoperative Thermal Kidney Insulation on Current Kidney Transplantation Surgical Practices
NA · iiShield · NCT07348458
This project will test a device called the Kidney Protective Jacket to help keep donated kidneys cooler during implantation for adults having their first or second kidney transplant.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iiShield (industry) |
| Locations | 1 site (Westmead, New South Wales) |
| Trial ID | NCT07348458 on ClinicalTrials.gov |
What this trial studies
This is a safety-focused interventional study using the Kidney Protective Jacket (KPJ) during kidney transplantation to limit re-warming of the organ during the anastomosis phase. The device is applied to donated kidneys removed from cold storage and is intended to reduce second warm ischemic time-related temperature rise that contributes to ischemia-reperfusion injury. The study will include suitable deceased and living donor kidneys transplanted into consenting adults (age ≥18) undergoing their first or second transplant, with exclusions for pediatric donor kidneys and silicone allergy. Investigators aim to use the device across a range of anatomical and procedural scenarios (single/multiple renal vessels, varying kidney sizes and recipient body sizes) to document safety in typical clinical practice.
Who should consider this trial
Good fit: Adults aged 18 or older receiving their first or second kidney transplant from a suitable deceased or living donor who can provide informed consent are the intended participants.
Not a fit: Patients receiving pediatric donor kidneys (donors under 16), those with a known silicone allergy, and recipients beyond a second transplant are excluded and therefore unlikely to benefit from this study.
Why it matters
Potential benefit: If safe and effective at limiting kidney re-warming, the device could reduce ischemia-reperfusion injury and improve early graft function and outcomes after transplant.
How similar studies have performed: Previous research has shown that keeping kidneys cooler during implantation can reduce temperature rise and related injury, but the Kidney Protective Jacket itself is a novel device with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Paediatric donor kidneys (kidneys from donors \< 16 years in age) * Patients with a known allergy or hypersensitivity to silicone
Where this trial is running
Westmead, New South Wales
- Westmead Hospital — Westmead, New South Wales, Australia (RECRUITING)
Study contacts
- Study coordinator: Amy Hort, MBBS (HONS), MS, FRACS
- Email: amy.hort@health.nsw.gov.au
- Phone: +61432782850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Transplant, Kidney transplant, Renal transplant, Second warm ischaemic time, Ischaemia-reperfusion injury, Kidney Protective Jacket, Graft cooling