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

• Sponsor: IceCure Medical Ltd. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02399124
• Collaborator: Bnai Zion Medical Center (Other), Shamir Medical Center (Other)
• Enrollment: 120
• Location: 1
• Arm: 1
• Duration (Months): 139.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Device: PROSENSE™	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ICE-SECRET PROSENSE™ Cryotherapy For Renal Cell Carcinoma Trial
• Study Start Date: Jul 1, 2014
• Anticipated Primary Completion Date: Feb 1, 2026
• Anticipated Study Completion Date: Feb 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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]

2. Recurrence free survival [up to 5 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bnei Zion Medical Center	Haifa		Israel

Sponsors and Collaborators

• IceCure Medical Ltd.
• Bnai Zion Medical Center
• Shamir Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: IceCure Medical Ltd.
• ClinicalTrials.gov Identifier: NCT02399124
• Other Study ID Numbers: ICMRC-01
• First Posted: Mar 26, 2015
• Last Update Posted: Aug 22, 2022
• Last Verified: Jun 1, 2022

• Keywords provided by IceCure Medical Ltd.: RCC; Renal Cell Carcinoma; Kidney tumors
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Renal Cell

Study Results

No Results Posted as of Aug 22, 2022