Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach

Part of paid clinical trials in Miami Lakes, Florida.

Sponsor
Urological Research Network, LLC
Study ID
NCT05218811
Status
Recruiting
Apply to this trial

Conditions

  • Kidney Neoplasms

Eligibility Criteria

Sex
ALL
Age
55 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cryoablation Assisted Partial Nephrectomy — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 15, 2020
Status verified
Jan 2023
Primary completion
May 15, 2026
Completion
May 15, 2041

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    Patients underwent Cryotheapy assisted partial nephrectomy

Primary Outcome Measure

Recurrence - Oncological Control [ Time Frame: 10 Years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Urological Research NetworkMiami LakesFlorida33016
CIELO GUERRA, BS
[email protected]
305-515-9887
FERNANDO J BIANCO, MD (PRINCIPAL_INVESTIGATOR)
EUSEBIO J LUNA, MD (SUB_INVESTIGATOR)

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By research site
Urological Research Network· Miami Lakes, FL

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