Renal cryoablation: Multidisciplinary, collaborative and perspective approach.
Mohamed Ismail, Tommy Kjærgaard Nielsen, Brunolf Lagerveld...
https://pubmed.ncbi.nlm.nih.gov/29890126Actively Recruiting
Led by Urological Research Network, LLC · Updated on 2023-01-26
150
Participants Needed
1
Research Sites
782 weeks
Total Duration
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
Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
Total: 1 location
1
Urological Research Network
Miami Lakes, Florida, United States, 33016
Actively Recruiting
E
Eusebio J Luna, MD
C
Cielo Guerra
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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