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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02399124
Recruitment Status : Recruiting
First Posted : March 26, 2015
Last Update Posted : March 16, 2018
Bnai Zion Medical Center
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Device: PROSENSE™ Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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 : July 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
single arm, open label, treatment
single arm, open label, treatment; ProSenseTM Cryoablation treatment, post marketing surveillance
single arm, open label, PROSENSE™ treatment

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. [ Time Frame: During intervention ]
  2. Recurrence free survival [ Time Frame: 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. [ Time Frame: a follow up visit at 1 month, 4 months, 8 months, 12 months and every 6 months afterwards up to 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 4cm 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02399124

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Contact: Elisabeth Sadka 972-4-6230333

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Bnei Zion Medical Center Recruiting
Haifa, Israel
Contact: Ofer Nativ, Prof.         
Asaf Harofe Medical center Recruiting
Zrifin, Israel
Principal Investigator: Amnon Zisman, Prof         
Sponsors and Collaborators
IceCure Medical Ltd.
Bnai Zion Medical Center
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Principal Investigator: Ofer Nativ, Prof. Bnei Zion Medical Center, Israel

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Responsible Party: IceCure Medical Ltd. Identifier: NCT02399124     History of Changes
Other Study ID Numbers: ICMRC-01
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Keywords provided by IceCure Medical Ltd.:
Renal Cell Carcinoma
Kidney tumors
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases