NCT05218811

Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach

Cryotherapy and Robotic Assisted Non Ischemic Nephron Sparring Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Urological Research Network, LLC · Academic / Other
• Sex: All
• Age: 55 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Patients with renal masses eligible to partial nephrectomy often require arterial ischemia to control or prevent blood loss during this surgical procedure. This study aims to determine the safety and efficacy of renal cryoablation at the tumor bed, as a substitute measure or technique vs total or selective arterial renal ischemia.

Detailed description

Nephron sparring surgery has emerged as the procedure of choice for most patients with renal tumors that are \>2 cm and harbor a greater than 50% exophitic component. In order to decrease blood loss surgeons may: 1- interrupt blood flow to the kidney, completely or selectively; 2-Use diuretics such as mannitol to dehydrate the kidney; 3-Ice externally the kidney - in open procedures - to decrease metabolism during ischemia. The emergence of robotic surgery triggered a shift in the the surgical approach to partial nephrectomy and is commonly employed. A fundamental drawback of this technique is represented on the lack of cold ischemia. However, warm ischemia is commonly employed and requires dissection of the renal pedicle, which by itself puts the kidney at risk of loss.

Conditions

• Kidney Neoplasms

Interventions

Type	Name	Description
DEVICE	Cryoablation Assisted Partial Nephrectomy	Cryoablation Assisted Partial Nephrectomy is monitored under Ultrasound guidance, A Cryoablation machine (FDA Approved Device) along with its Cryoprobes are used in the study The Cryoprobes are placed in close to the endophytic tumor margins. The tumor boundary area will undergo one freezing cycles. Tumor is excised after 5 minutes of freezing cycle. Thawing process is passive, renal defect repair is conducted during thawing process.

Timeline

• Start date: 2020-05-15
• Primary completion: 2026-05-15
• Completion: 2041-05-15
• First posted: 2022-02-01
• Last updated: 2023-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study