Trial record 1 of 1 for:
ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial (ICE-CRYSTAL)
This study has been completed.
Information provided by (Responsible Party):
IceCure Medical Ltd.
First received: May 28, 2009
Last updated: February 7, 2013
Last verified: February 2013
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Evaluation of Safety and Feasibility of the ICE-SENSE™, a Cryotherapy Device for Office-based Ultrasound-guided Treatment of Breast Fibroadenoma
Primary Outcome Measures:
- engulfment of the tumor by the ice-ball as seen under ultrasound imaging [ Time Frame: during the procedure ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- any device related adverse events or complications that may occur [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2013 (Final data collection date for primary outcome measure)
Experimental: Breast Fibroadenoma
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910312
|Oncogynecological Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague
|Prague, Czech Republic, 128 00 |
|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 |
IceCure Medical Ltd.
||Rafi Klein, Dr.
No publications provided
||IceCure Medical Ltd.
History of Changes
|Other Study ID Numbers:
||AM-03, version 5.0
|Study First Received:
||May 28, 2009
||February 7, 2013
||Czech Republic: Ethics Committee and State Institute for Drug Control(SUKL)
Germany: German Institute of Medical Documentation and Information
Israel:Ministry Of Health (MOH)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial