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

Renal Cell Carcinoma Clinical Trial

— ICE-SECRET  

Official title:

ICE-SECRET PROSENSE™ Cryotherapy For Renal Cell Carcinoma Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02399124
• Other study ID #: ICMRC-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2014
• Est. completion date: February 2026

Study information

• Verified date: March 2024
• Source: IceCure Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Device:
• PROSENSE™
single arm, open label, PROSENSE™ treatment

Locations

Country	Name	City	State
Israel	Bnei Zion Medical Center	Haifa
Israel	Shamir Medical Center	Zerifin

Sponsors (3)

Lead Sponsor	Collaborator
IceCure Medical Ltd.	Assaf-Harofeh Medical Center, Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Recurrence free survival		up to 5 years
Secondary	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