Kidney Protective Jacket

Sponsor
iiShield
Study ID
NCT07348458
Status
Recruiting
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Conditions

  • Kidney Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Kidney Protective Jacket — DEVICE
    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 Details

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.

Key Dates

First listed
Jan 16, 2026
Start date
Mar 1, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Kidney Protective Jacket
    Application of the KPJ to the renal transplant.

Primary Outcome Measure

Safety of the Kidney Protective Jacket [ 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. ]

Central Contacts

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