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ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial (ICE-CRYSTAL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00910312
First Posted: May 29, 2009
Last Update Posted: April 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
IceCure Medical Ltd.
  Purpose
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.

Condition Intervention
Fibroadenoma Device: Ice-Sense

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Feasibility of the ICE-SENSE™, a Cryotherapy Device for Office-based Ultrasound-guided Treatment of Breast Fibroadenoma

Further study details as provided by IceCure Medical Ltd.:

Primary Outcome Measures:
  • engulfment of the tumor by the ice-ball as seen under ultrasound imaging [ Time Frame: during the procedure ]

Secondary Outcome Measures:
  • any device related adverse events or complications that may occur [ Time Frame: one year ]

Enrollment: 54
Study Start Date: April 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breast Fibroadenoma Device: Ice-Sense
Ice-Sense Cryoprobe

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910312


Locations
Czech Republic
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
Germany
Department of Obstetrics and Gynecology, University Hospital of Heidelberg
Heidelberg, Germany
Department of Obstetrics and Gynecology, University Hospital of Tuebingen
Tübingen, Germany
Israel
Assuta medical centers
Haifa, Israel
Sponsors and Collaborators
IceCure Medical Ltd.
Investigators
Principal Investigator: Rafi Klein, Dr.
  More Information

Responsible Party: IceCure Medical Ltd.
ClinicalTrials.gov Identifier: NCT00910312     History of Changes
Other Study ID Numbers: AM-03
version 5.0
First Submitted: May 28, 2009
First Posted: May 29, 2009
Last Update Posted: April 22, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Fibroadenoma
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial