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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IceCure Medical Ltd.
ClinicalTrials.gov Identifier:
NCT00910312
First received: May 28, 2009
Last updated: February 7, 2013
Last verified: February 2013
History of Changes

May 28, 2009
February 7, 2013
April 2009
January 2013   (final data collection date for primary outcome measure)
engulfment of the tumor by the ice-ball as seen under ultrasound imaging [ Time Frame: during the procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00910312 on ClinicalTrials.gov Archive Site
any device related adverse events or complications that may occur [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial
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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Fibroadenoma
Device: Ice-Sense
Ice-Sense Cryoprobe
Experimental: Breast Fibroadenoma
Intervention: Device: Ice-Sense
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   Israel
 
NCT00910312
AM-03, version 5.0
No
IceCure Medical Ltd.
IceCure Medical Ltd.
Not Provided
Principal Investigator: Rafi Klein, Dr.
IceCure Medical Ltd.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP