RecruitingNot ApplicableNCT05218811

Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach

Cryotherapy and Robotic Assisted Non Ischemic Nephron Sparring Surgery


Sponsor

Urological Research Network, LLC

Enrollment

150 participants

Start Date

May 15, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 55 YearsMax Age: 65 Years

Inclusion Criteria2

  • Patients with ages between 45-90-year-old.
  • Renal tumor ≤ 7 cm in the greatest extension, \>50% exophitic.

Exclusion Criteria2

  • Prior renal surgery
  • M1 Disease

Interventions

DEVICECryoablation 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.


Locations(1)

Urological Research Network

Miami Lakes, Florida, United States

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NCT05218811


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