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NCT Number: NCT02399124

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bnei Zion Medical Center, Haifa, Israel

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

PROSENSE™

Device

single arm, open label, PROSENSE™ treatment

Primary outcomes

  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.

    Time frame: During intervention

    % of procedures with sufficient engulfment

  2. Recurrence free survival

    Time frame: up to 5 years

    % of local recurrence events

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.

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

Sponsors and collaborators

Lead sponsor

IceCure Medical Ltd.

Industry

Collaborators

  • Assaf-Harofeh Medical Center
  • Bnai Zion Medical Center

Registry information

Official study title

ICE-SECRET PROSENSE™ Cryotherapy For Renal Cell Carcinoma Trial

Acronym: ICE-SECRET

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Mar 26, 2015
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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