Cryoablation to assist in kidney tumor surgery
Cryotherapy and Robotic Assisted Non Ischemic Nephron Sparring Surgery
This study is testing whether using cryoablation during kidney tumor surgery can help patients lose less blood and have better results compared to traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 55 Years to 65 Years |
| Sex | All |
| Sponsor | Urological Research Network, LLC Academic / other |
| Locations | 1 site (Miami Lakes, Florida) |
| Trial ID | NCT05218811 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of using renal cryoablation at the tumor site during partial nephrectomy, as an alternative to traditional methods that involve arterial ischemia to control bleeding. The focus is on patients with renal masses that are suitable for nephron-sparing surgery, particularly those with tumors larger than 2 cm. The study aims to determine if cryoablation can reduce blood loss and improve surgical outcomes without the need for blood flow interruption. The approach is particularly relevant in the context of robotic-assisted surgeries, which may lack cold ischemia.
Who should consider this trial
Good fit: Ideal candidates are patients aged 45-90 with renal tumors measuring 7 cm or less and having more than 50% of the tumor exophytic.
Not a fit: Patients with prior renal surgery or metastatic disease (M1) may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer kidney surgeries with reduced blood loss and better preservation of kidney function.
How similar studies have performed: While the use of cryoablation in kidney surgery is established, this specific non-ischemic approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Miami Lakes, Florida
- Urological Research Network — Miami Lakes, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Fernando J Bianco, MD — Urological research Network
- Study coordinator: Eusebio J Luna, MD
- Email: drluna@research.surgery
- Phone: 3058227227
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.