Renal Cell CarcinomaICE-SECRETNCT02399124
Post Marketing Surveillance for PROSENSE™ a Cryotherapy Treatment of Renal Cell Carcinoma
A study testing PROSENSE™ in people with Renal Cell Carcinoma, run by IceCure Medical Ltd. at 2 sites in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- PROSENSE™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesIsrael
- Study dates
- Jul 2014to 26 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Bnei Zion Medical Center
Haifa
Shamir Medical Center
Tsrifin, 70300
About this study
Official title: 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).
Read the detailed description
A post marketing data collection of a cryosurgical system [PROSENSE™] of IceCure Medical], for the treatment of renal cell carcinoma (RCC).
- Conditions
- Renal Cell Carcinoma
- Being tested
- PROSENSE™
- Keywords
- RCC, Renal Cell Carcinoma, Kidney tumors
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROSENSE™Device
single arm, open label, PROSENSE™ treatment
| Study group | Role | What they receive |
|---|---|---|
| single arm, open label, treatment | Other | single arm, open label, treatment; ProSenseTM Cryoablation treatment, post marketing surveillance Receives: Device: PROSENSE™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
% of procedures with sufficient engulfment
Measured: During intervention
Recurrence free survival
% of local recurrence events
Measured: up to 5 years
Secondary outcomes (1)
Success in verification of the ProSense™ safety as demonstrated by having no complications related to the cryoablation procedure other than the well-known ones.
Measured: a follow up visit at 6 weeks, 6 months, 12 months and every 1 year afterwards up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startJul 2014
- Primary completionFeb 2026
- Study completion26 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IceCure Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bnai Zion Medical Center, Assaf-Harofeh Medical Center
- Responsible party
- Sponsor
- Investigators
- Halachmi Sarel, Prof., Principal investigator, Bnei Zion Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399124
- Sponsor's protocol ID
- ICMRC-01
- Acronym
- ICE-SECRET
- Status last verified
- Oct 2026
- First submitted
- 27 Jan 2015
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICE-SECRET PROSENSE™ Cryotherapy For Renal Cell Carcinoma Trial
- ClinicalTrials.gov ID
- NCT02399124
- Acronym / sponsor ID
- ICE-SECRET / ICMRC-01
- Conditions
- Renal Cell Carcinoma
- Keywords
- RCC, Renal Cell Carcinoma, Kidney tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- IceCure Medical Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Bnai Zion Medical Center, Assaf-Harofeh Medical Center
- Study start
- Jul 2014 (actual)
- Primary completion
- Feb 2026 (actual)
- Study completion
- 26 Jul 2026 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm, open label, treatment | Other | Device: PROSENSE™single arm, open label, treatment; ProSenseTM Cryoablation treatment, post marketing surveillance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROSENSE™single arm, open label, PROSENSE™ treatment | Device | single arm, open label, treatment |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halachmi Sarel, Prof. principal investigator
Bnei Zion Medical Center, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROSENSE™ in people with Renal Cell Carcinoma, run by IceCure Medical Ltd. at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.