ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial
ICE-CRYSTAL
Evaluation of Safety and Feasibility of the ICE-SENSE™, a Cryotherapy Device for Office-based Ultrasound-guided Treatment of Breast Fibroadenoma
2 other identifiers
interventional
54
3 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2009
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 28, 2009
CompletedFirst Posted
Study publicly available on registry
May 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedAugust 17, 2022
April 1, 2016
3.8 years
May 28, 2009
August 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
engulfment of the tumor by the ice-ball as seen under ultrasound imaging
during the procedure
Secondary Outcomes (1)
any device related adverse events or complications that may occur
one year
Study Arms (1)
Breast Fibroadenoma
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Oncogynecological Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague
Prague, 128 00, Czechia
Department of Obstetrics and Gynecology, University Hospital of Heidelberg
Heidelberg, Germany
Department of Obstetrics and Gynecology, University Hospital of Tuebingen
Tübingen, Germany
Assuta medical centers
Haifa, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rafi Klein, Dr.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2009
First Posted
May 29, 2009
Study Start
April 1, 2009
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
August 17, 2022
Record last verified: 2016-04