Post Marketing Surveillance for PROSENSE™ a Cryotherapy Treatment of Renal Cell Carcinoma

ICE-SECRET PROSENSE™ Cryotherapy For Renal Cell Carcinoma Trial

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02399124

Acronym

ICE-SECRET

Enrollment

120

Registered

2015-03-26

Start date

2014-07-31

Completion date

2026-03-31

Last updated

2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Keywords

RCC, Renal Cell Carcinoma, Kidney tumors

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).

Interventions

DEVICEPROSENSE™

single arm, open label, PROSENSE™ treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.	During intervention	% of procedures with sufficient engulfment
Recurrence free survival	up to 5 years	% of local recurrence events

Secondary

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.	a follow up visit at 6 weeks, 6 months, 12 months and every 1 year afterwards up to 5 years

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026