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Cryoablation
Cryoablation-Assisted Surgery for Kidney Cancer (RCAPN Trial)
N/A
Recruiting
Led By Fernando J Bianco, MD
Research Sponsored by Urological Research Network, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with ages between 45-90-year-old
Renal tumor ≤ 7 cm in the greatest extension, >50% exophitic
Must not have
M1 Disease
Prior renal surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare two methods of controlling blood loss during surgery for kidney cancer: renal cryoablation (freezing the tumor) and selective arterial renal ischemia (restricting blood flow to the kidney).
Who is the study for?
This trial is for individuals aged 45-90 with kidney tumors that are less than 7 cm large and mostly on the outside of the kidney. It's not suitable for those who've had previous kidney surgery or have metastatic disease, where cancer has spread to other parts of the body.
What is being tested?
The study tests a new method called Cryoablation Assisted Partial Nephrectomy in patients with renal masses. This technique might help control blood loss during surgery without stopping blood flow to the kidney, which is usually done by arterial ischemia.
What are the potential side effects?
While specific side effects aren't listed here, cryoablation procedures can typically include pain at the treatment site, bleeding, infection risks, and potential damage to nearby tissues or organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 45 and 90 years old.
Select...
My kidney tumor is 7 cm or smaller and mostly on the outside of the kidney.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread to distant parts of my body.
Select...
I have had kidney surgery in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Recurrence - Oncological Control
Secondary study objectives
Development or Progression of Chronic Kidney Disease (CKD)
Incidence of Metastatic disease
Local Re-Intervention
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment groupExperimental Treatment1 Intervention
Patients underwent Cryotheapy assisted partial nephrectomy
Find a Location
Who is running the clinical trial?
Urological Research Network, LLCLead Sponsor
4 Previous Clinical Trials
10,040 Total Patients Enrolled
Fernando J Bianco, MDPrincipal InvestigatorUrological research Network
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to distant parts of my body.I have had kidney surgery in the past.I am between 45 and 90 years old.My kidney tumor is 7 cm or smaller and mostly on the outside of the kidney.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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