Back to resultsICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial (ICE-CRYSTAL)
Primary Purpose
Fibroadenoma
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ice-Sense
Sponsored by
About this trial
This is an interventional treatment trial for Fibroadenoma
Eligibility Criteria
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.
Sites / Locations
- Oncogynecological Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague
- Department of Obstetrics and Gynecology, University Hospital of Heidelberg
- Department of Obstetrics and Gynecology, University Hospital of Tuebingen
- Assuta medical centers
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Breast Fibroadenoma
Arm Description
Outcomes
Primary Outcome Measures
engulfment of the tumor by the ice-ball as seen under ultrasound imaging
Secondary Outcome Measures
any device related adverse events or complications that may occur
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00910312
Brief Title
ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial
Acronym
ICE-CRYSTAL
Official Title
Evaluation of Safety and Feasibility of the ICE-SENSE™, a Cryotherapy Device for Office-based Ultrasound-guided Treatment of Breast Fibroadenoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IceCure Medical Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibroadenoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breast Fibroadenoma
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ice-Sense
Intervention Description
Ice-Sense Cryoprobe
Primary Outcome Measure Information:
Title
engulfment of the tumor by the ice-ball as seen under ultrasound imaging
Time Frame
during the procedure
Secondary Outcome Measure Information:
Title
any device related adverse events or complications that may occur
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafi Klein, Dr.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncogynecological Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague
City
Prague
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
Department of Obstetrics and Gynecology, University Hospital of Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Department of Obstetrics and Gynecology, University Hospital of Tuebingen
City
Tübingen
Country
Germany
Facility Name
Assuta medical centers
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial
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