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Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach

NCT05218811 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-01-26

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Urological Research Network, LLC

    lead OTHER

Principal Investigators

  • Fernando J Bianco, MD · Urological research Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-15
Primary Completion
2026-05-15
Completion
2041-05-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05218811 on ClinicalTrials.gov