- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00910312
ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial (ICE-CRYSTAL)
August 16, 2022 updated by: IceCure Medical Ltd.
Evaluation of Safety and Feasibility of the ICE-SENSE™, a Cryotherapy Device for Office-based Ultrasound-guided Treatment of Breast Fibroadenoma
The purpose of this study is to determine whether the Ice-Sense, a novel cryotherapy system (a system that freezes tissues), is safe and effective in the treatment of benign breast tumors such as fibroadenoma.
Study Overview
Study Type
Interventional
Enrollment (Actual)
54
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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Prague, Czechia, 128 00
- Oncogynecological Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague
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Heidelberg, Germany
- Department of Obstetrics and Gynecology, University Hospital of Heidelberg
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Tübingen, Germany
- Department of Obstetrics and Gynecology, University Hospital of Tuebingen
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Haifa, Israel
- Assuta Medical Centers
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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
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patient is above 18 years old.
- Patient has breast fibroadenoma, proven by biopsy (Core Biopsy).
- Patient's fibroadenoma can be visualized with ultrasound.
- Patient's fibroadenoma size is between 0.5cm and 3cm at its largest dimension.
- Patient is able to visit the clinic as needed during the 12-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/EC approved written informed consent, including data privacy authorization.
Exclusion Criteria:
- Patients with history of breast cancer.
- Women with known pregnancy.
- Patients with superficial fibroadenoma very close to the skin.
- Patient has undergone major surgery within the previous 12 weeks.
- Patients with any terminal illness, or with a life expectancy <2 year.
- Patients carrying contagious diseases such as Tuberculosis Hepatitis or AIDS.
- 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 |
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Experimental: Breast Fibroadenoma
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Ice-Sense Cryoprobe
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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engulfment of the tumor by the ice-ball as seen under ultrasound imaging
Time Frame: during the procedure
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during the procedure
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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any device related adverse events or complications that may occur
Time Frame: one year
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one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rafi Klein, Dr.
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
April 1, 2009
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
May 28, 2009
First Submitted That Met QC Criteria
May 28, 2009
First Posted (Estimate)
May 29, 2009
Study Record Updates
Last Update Posted (Actual)
August 17, 2022
Last Update Submitted That Met QC Criteria
August 16, 2022
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AM-03
- version 5.0
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.
Clinical Trials on Fibroadenoma
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TheraclionUnknownBreast FibroadenomaBulgaria
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TheraclionCompleted
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TheraclionCompleted
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David R. Brenin, MDTheraclion SAS, Paris, FranceCompletedBreast FibroadenomaUnited States
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University Women's Hospital TübingenTheraclionCompletedBreast FibroadenomaGermany
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InSightecTerminatedBreast FibroadenomaUnited States, Japan
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TheraclionRecruitingBreast FibroadenomaUnited States
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QT Ultrasound LLCCompletedBreast FibroadenomaUnited States
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TheraclionTerminatedBreast FibroadenomaFrance
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TheraclionCompletedBreast FibroadenomaGermany
Clinical Trials on Ice-Sense
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Washington State UniversityNational Institute of Nursing Research (NINR)Completed
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Brigham and Women's HospitalPOM Wonderful LLCRecruiting
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Vanderbilt University Medical CenterNational Institute of Mental Health (NIMH)Active, not recruiting
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Common SenseCompletedAmniotic ProblemsUnited States
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Western Galilee Hospital-NahariyaCommon SenseUnknownPremature Birth | Abortion, Spontaneous | Vaginosis, BacterialIsrael
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Sense Diagnostics, LLCCompletedStroke, Acute | Stroke Hemorrhagic | Intracerebral HemorrhageUnited States
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Common SenseWithdrawn
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Common SenseCompletedAMNIOTIC FLUID LEAKAGE