Back to resultsPost Marketing Surveillance for PROSENSE™ a Cryotherapy Treatment of Renal Cell Carcinoma (ICE-SECRET)
Primary Purpose
Renal Cell Carcinoma
Status
Active
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
PROSENSE™
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring RCC, Renal Cell Carcinoma, Kidney tumors
Eligibility Criteria
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.
Sites / Locations
- Bnei Zion Medical Center
- Shamir Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
single arm, open label, treatment
Arm Description
single arm, open label, treatment; ProSenseTM Cryoablation treatment, post marketing surveillance
Outcomes
Primary Outcome Measures
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.
Recurrence free survival
Secondary Outcome Measures
Success in verification of the ProSense™ safety as demonstrated by having no complications related to the cryoablation procedure other than the well-known ones.
Full Information
NCT ID
NCT02399124
First Posted
January 27, 2015
Last Updated
December 21, 2022
Sponsor
IceCure Medical Ltd.
Collaborators
Bnai Zion Medical Center, Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02399124
Brief Title
Post Marketing Surveillance for PROSENSE™ a Cryotherapy Treatment of Renal Cell Carcinoma
Acronym
ICE-SECRET
Official Title
ICE-SECRET PROSENSE™ Cryotherapy For Renal Cell Carcinoma Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IceCure Medical Ltd.
Collaborators
Bnai Zion Medical Center, Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
RCC, Renal Cell Carcinoma, Kidney tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single arm, open label, treatment
Arm Type
Other
Arm Description
single arm, open label, treatment; ProSenseTM Cryoablation treatment, post marketing surveillance
Intervention Type
Device
Intervention Name(s)
PROSENSE™
Intervention Description
single arm, open label, PROSENSE™ treatment
Primary Outcome Measure Information:
Title
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
Title
Recurrence free survival
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
Success in verification of the ProSense™ safety as demonstrated by having no complications related to the cryoablation procedure other than the well-known ones.
Time Frame
a follow up visit at 6 weeks, 6 months, 12 months and every 1 year afterwards up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halachmi Sarel, Prof.
Organizational Affiliation
Bnei Zion Medical Center, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bnei Zion Medical Center
City
Haifa
Country
Israel
Facility Name
Shamir Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Post Marketing Surveillance for PROSENSE™ a Cryotherapy Treatment of Renal Cell Carcinoma
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