- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02399124
Post Marketing Surveillance for PROSENSE™ a Cryotherapy Treatment of Renal Cell Carcinoma (ICE-SECRET)
March 4, 2024 updated by: IceCure Medical Ltd.
ICE-SECRET PROSENSE™ Cryotherapy For Renal Cell Carcinoma Trial
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).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
A post marketing data collection of a cryosurgical system [PROSENSE™] of IceCure Medical], for the treatment of renal cell carcinoma (RCC).
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Haifa, Israel
- Bnei Zion Medical Center
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Zerifin, Israel, 70300
- Shamir medical center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: single arm, open label, treatment
single arm, open label, treatment; ProSenseTM Cryoablation treatment, post marketing surveillance
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single arm, open label, PROSENSE™ treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
During intervention
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Recurrence free survival
Time Frame: up to 5 years
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up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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a follow up visit at 6 weeks, 6 months, 12 months and every 1 year afterwards up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Halachmi Sarel, Prof., Bnei Zion Medical Center, Israel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Estimated)
February 1, 2026
Study Completion (Estimated)
February 1, 2026
Study Registration Dates
First Submitted
January 27, 2015
First Submitted That Met QC Criteria
March 25, 2015
First Posted (Estimated)
March 26, 2015
Study Record Updates
Last Update Posted (Actual)
March 6, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma, Renal Cell
- Carcinoma
Other Study ID Numbers
- ICMRC-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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