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

August 16, 2022 updated by: IceCure Medical Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Prague, Czechia, 128 00
        • Oncogynecological Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague
      • Heidelberg, Germany
        • Department of Obstetrics and Gynecology, University Hospital of Heidelberg
      • Tübingen, Germany
        • Department of Obstetrics and Gynecology, University Hospital of Tuebingen
      • Haifa, Israel
        • Assuta Medical Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breast Fibroadenoma
Ice-Sense Cryoprobe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
engulfment of the tumor by the ice-ball as seen under ultrasound imaging
Time Frame: during the procedure
during the procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
any device related adverse events or complications that may occur
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rafi Klein, Dr.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

May 28, 2009

First Posted (Estimate)

May 29, 2009

Study Record Updates

Last Update Posted (Actual)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

April 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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