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

NCT02399124 | Active Not Recruiting

• 1 other identifier: ICMRC-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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).

Conditions

Renal Cell Carcinoma

Keywords

RCC; Renal Cell Carcinoma; Kidney tumors

Outcome Measures

Primary Outcomes (2)

• 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

  During intervention

• Recurrence free survival

  % of local recurrence events

  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.

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

Study Arms (1)

single arm, open label, treatment

OTHER

single arm, open label, treatment; ProSenseTM Cryoablation treatment, post marketing surveillance

Device: PROSENSE™

Interventions

PROSENSE™ DEVICE

single arm, open label, PROSENSE™ treatment

single arm, open label, treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bnai Zion Medical Center: collaborator
• Assaf-Harofeh Medical Center: collaborator
• IceCure Medical Ltd.: lead

Study Sites (2)

Bnei Zion Medical Center

Haifa, Israel

Location

Shamir Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Halachmi Sarel, Prof.

  Bnei Zion Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: March 26, 2015
• Study Start: July 1, 2014
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-04

Locations

IL (2)