Recruiting

Renal Cryoablation vs. Arterial Ischemia

Sponsor:

Urological Research Network, LLC

Code:

NCT05218811

Conditions

Kidney Neoplasms

Eligibility Criteria

Sex: All

Age: 55 - 65

Healthy Volunteers: Not accepted

Interventions

Cryoablation Assisted Partial Nephrectomy

Study Details

Brief 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.

Conditions

Kidney Neoplasms

Study ID

NCT05218811

Start date

May 15, 2020

Status verified date

Jan, 2023

Completion date

May 15, 2041

Anticipated

Primary completion date

May 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior renal surgery
  • M1 Disease

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment group

Patients underwent Cryotheapy assisted partial nephrectomy

Interventions

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.

Primary outcome measure

  • Recurrence - Oncological Control [ Time Frame: 10 Years ]

Central Contacts and Locations

Central contacts

Eusebio J Luna, MD

3058227227drluna@research.surgery

Cielo Guerra

3058227227cielo@besturology.net

Locations

Urological Research Network

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

CIELO GUERRA, BS

305-515-9887CIELO@BESTUROLOGY.NET

Principal Investigator:

FERNANDO J BIANCO, MD

More Information

Sponsor

Urological Research Network, LLC

Last update posted

Jan 26, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Urological Research Network, LLC on 2023-01-26.