Actively Recruiting

Phase Not Applicable
Age: 55Years - 65Years
All Genders
ID05218811

Cryotherapy and Robotic Assisted Non Ischemic Nephron Sparing Surgery

Led by Urological Research Network, LLC · Updated on 2023-01-26

150

Participants Needed

1

Research Sites

782 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates a new surgical method for patients with kidney tumors who are candidates for partial nephrectomy, a procedure that removes part of the kidney. The study aims to compare the safety and effectiveness of using cryoablation at the tumor site instead of the usual approach that temporarily stops blood flow to the kidney during surgery. This alternative technique could address risks associated with current methods that involve warm ischemia, which can harm the kidney. Participants receive a treatment called Cryoablation Assisted Partial Nephrectomy, guided by ultrasound and using a specialized FDA-approved cryoablation device. During surgery, cryoprobes are placed near the tumor margins to freeze the tumor boundary in one cycle lasting five minutes. After freezing, the tumor is removed, and the kidney is repaired while the tissue thaws naturally. This approach avoids the need for interrupting blood flow to the kidney. Throughout the study, participants will be monitored for up to ten years to assess outcomes such as cancer recurrence, the need for additional local treatments, development or worsening of chronic kidney disease, spread of cancer, and overall survival. Researchers will collect data from regular follow-ups to evaluate the long-term safety and success of this cryoablation-assisted technique compared to traditional methods.

CONDITIONS

Brief Title

Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach

Who Can Participate

Age: 55Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 45 and 90 years old
  • Renal tumor 7 cm or smaller in greatest size
  • Tumor has more than 50% of its mass outside the kidney (exophytic)
Not Eligible

You will not qualify if you...

  • Prior kidney surgery
  • Metastatic kidney cancer (M1 disease)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Single surgical procedure with immediate post-operative care

Participants undergo Cryoablation Assisted Partial Nephrectomy, where a cryoablation device is used under ultrasound guidance to freeze and excise the tumor while preserving kidney tissue.

1 surgical visit and several immediate post-operative visits

Post-operative Follow-up

Duration - Up to 10 years

Participants are monitored after surgery to assess recovery and kidney function as well as cancer control.

Periodic follow-up visits over 10 years

Trial Site Locations

Total: 1 location

1

Urological Research Network

Miami Lakes, Florida, United States, 33016

Actively Recruiting

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Research Team

E

Eusebio J Luna, MD

C

Cielo Guerra

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Cryoablation for Small Renal Masses: Selection Criteria, Complications, and Functional and Oncologic Results.

Homayoun Zargar, Thomas D Atwell, Jeffrey A Cadeddu...

https://pubmed.ncbi.nlm.nih.gov/25819723