ICE-SECRET PROSENSE™ Cryotherapy For Renal Cell Carcinoma Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- IceCure Medical Ltd.
- Enrollment
- 120
- Locations
- 3
- Primary Endpoint
- Success in creating an ice ball that engulfs the whole tumor with 5 mm margins using the ProSense™ as seen under laparoscopic, US or CT imaging during the procedure.
Study Overview
Brief Summary
This experiment is designed for post marketing data collection of a cryosurgical system [PROSENSE™ of IceCure Medical], for the treatment of renal cell carcinoma (RCC).
Detailed Description
A post marketing data collection of a cryosurgical system [PROSENSE™] of IceCure Medical], for the treatment of renal cell carcinoma (RCC).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient is above 18 years old.
- •The patient has enhanced solid mass of renal origin located in the kidney or elsewhere proved by imaging.
- •Patient's mass size is up to 5 cm at its largest dimension.
- •Patient is able to visit the clinic as needed during the 60-month follow-up period following the cryoablation procedure.
- •The patient has been informed of the study and agrees to its provisions, and has signed an IRB approved written informed consent, including data privacy authorization.
Exclusion Criteria
- •Patients with permanent coagulation disorders or severe medical instability or active infection.
- •Patients with any terminal illness.
- •Patient participating in other trials using drugs or devices.
Arms & Interventions
single arm, open label, treatment
single arm, open label, treatment; ProSenseTM Cryoablation treatment, post marketing surveillance
Intervention: PROSENSE™ (Device)
Outcomes
Primary Outcomes
Success in creating an ice ball that engulfs the whole tumor with 5 mm margins using the ProSense™ as seen under laparoscopic, US or CT imaging during the procedure.
Time Frame: During intervention
% of procedures with sufficient engulfment
Recurrence free survival
Time Frame: up to 5 years
% of local recurrence events
Secondary Outcomes
- Success in verification of the ProSense™ safety as demonstrated by having no complications related to the cryoablation procedure other than the well-known ones.(a follow up visit at 6 weeks, 6 months, 12 months and every 1 year afterwards up to 5 years)