ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial

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.

Completed

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Key information

Conditions

Fibroadenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibroepithelial Neoplasms, Fibrous Tissue Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oncogynecological Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Prague, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ice-Sense

Device

Ice-Sense Cryoprobe

Primary outcomes

engulfment of the tumor by the ice-ball as seen under ultrasound imaging

Time frame: during the procedure

Secondary outcomes

any device related adverse events or complications that may occur

Time frame: one year

Sponsors and collaborators

Lead sponsor

IceCure Medical Ltd.

Industry

Registry information

Official study title

Evaluation of Safety and Feasibility of the ICE-SENSE™, a Cryotherapy Device for Office-based Ultrasound-guided Treatment of Breast Fibroadenoma

Acronym: ICE-CRYSTAL

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: May 29, 2009
Registry last updated: Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed