Trial record 1 of 1 for:    NCT00910312
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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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: IceCure Medical Ltd.
ClinicalTrials.gov Identifier: NCT00910312     History of Changes
Other Study ID Numbers: AM-03, version 5.0
Study First Received: May 28, 2009
Last Updated: February 7, 2013
Health Authority: 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:
Fibroadenoma
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 29, 2014