Post Marketing Surveillance for PROSENSE™ a Cryotherapy Treatment of Renal Cell Carcinoma (ICE-SECRET)

January 1, 2026 updated by: IceCure Medical Ltd.

ICE-SECRET PROSENSE™ Cryotherapy For Renal Cell Carcinoma Trial

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A post marketing data collection of a cryosurgical system [PROSENSE™] of IceCure Medical], for the treatment of renal cell carcinoma (RCC).

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Bnei Zion Medical Center
      • Ẕerifin, Israel, 70300
        • Shamir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient is above 18 years old.
  2. The patient has enhanced solid mass of renal origin located in the kidney or elsewhere proved by imaging.
  3. Patient's mass size is up to 5 cm at its largest dimension.
  4. Patient is able to visit the clinic as needed during the 60-month follow-up period following the cryoablation procedure.
  5. 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:

  1. Patients with permanent coagulation disorders or severe medical instability or active infection.
  2. Patients with any terminal illness.
  3. Patient participating in other trials using drugs or devices.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: single arm, open label, treatment
single arm, open label, treatment; ProSenseTM Cryoablation treatment, post marketing surveillance
Device: PROSENSE™
single arm, open label, PROSENSE™ treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During intervention
Recurrence free survival
Time Frame: up to 5 years
% of local recurrence events
up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
a follow up visit at 6 weeks, 6 months, 12 months and every 1 year afterwards up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IceCure Medical Ltd.

Collaborators

Assaf-Harofeh Medical Center
Bnai Zion Medical Center

Investigators

  • Principal Investigator: Halachmi Sarel, Prof., Bnei Zion Medical Center, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 27, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimated)

March 26, 2015

Study Record Updates

Last Update Posted (Estimated)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 1, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICMRC-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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