Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
Study NCT ID:
NCT05166460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-21
First Post:
2021-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation
Sponsor:
Thomas Skinner
Organization:
Study Overview
Official Title:
Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QuitWIT
Brief Summary:
Avoiding warm ischemia time during vascular anastomosis of the renal allograft is important to prevent damage. The investigators are studying a cooling device that may control the temperature of the renal allograft during transplant surgery; attempting to keep temperatures at or below 5°C for at least 60 minutes. If found effective, this could eliminate warm ischemia and potentially prevent damage to transplanted kidneys.
Detailed Description:
Warm ischemia can damage a renal allograft in many different ways often leading to early failure of the kidney transplant and sometimes even death of the transplant recipient. For this reason every effort is made to keep the allograft cold during the removal and transportation, and protocols have been developed to ensure this. Although kidneys are kept below 5°C during transportation, they re-warm rapidly during the transplant surgery. On average, kidneys are exposed to 40 or more minutes of dangerously warm temperatures during transplant surgery.
To avoid damage, it is important to reduce the amount of time it is exposed to warm temperatures. Currently, there are no devices or standardized protocols available to ensure a kidney stays cold during the transplant surgery.
The Principal Investigator has developed Kidney Skinn, a device that may control the temperature of the renal allograft during transplant surgery; keeping allograft temperatures at or below 5°C for at least 60 minutes. If found effective, this could eliminate warm ischemia and potentially prevent damage to transplanted kidneys. The device may also potentially provide retraction and support for the kidney during the transplant operation, making the surgery easier to perform. Additionally, the device may be found to be easily removed once the transplant is complete.
A previous study was conducted with the Kidney Skinn in animals; the next step is to investigate whether the device can perform in the human clinical setting. This study will be done in 2 steps. Part A: a series of consecutive consenting patients to determine device initial safety, and Part B: a single-centre randomized-controlled pilot study of kidney transplant recipients.
To avoid damage, it is important to reduce the amount of time it is exposed to warm temperatures. Currently, there are no devices or standardized protocols available to ensure a kidney stays cold during the transplant surgery.
The Principal Investigator has developed Kidney Skinn, a device that may control the temperature of the renal allograft during transplant surgery; keeping allograft temperatures at or below 5°C for at least 60 minutes. If found effective, this could eliminate warm ischemia and potentially prevent damage to transplanted kidneys. The device may also potentially provide retraction and support for the kidney during the transplant operation, making the surgery easier to perform. Additionally, the device may be found to be easily removed once the transplant is complete.
A previous study was conducted with the Kidney Skinn in animals; the next step is to investigate whether the device can perform in the human clinical setting. This study will be done in 2 steps. Part A: a series of consecutive consenting patients to determine device initial safety, and Part B: a single-centre randomized-controlled pilot study of kidney transplant recipients.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: