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

Not Applicable

Active, not recruiting

• Conditions: Renal Cell Carcinoma
• Interventions: Device: PROSENSE™

• Registration Number: NCT02399124
• Lead Sponsor: IceCure Medical Ltd.

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).

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-01-27
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm, open label, treatment	PROSENSE™	single arm, open label, treatment; ProSenseTM Cryoablation treatment, post marketing surveillance

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Shamir Medical Center; 🇮🇱 Zerifin, Israel

Bnei Zion Medical Center; 🇮🇱 Haifa, Israel