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

IceCure Medical

Status: Completed

Conditions: Fibroadenoma

Treatments: Device: Ice-Sense

Study type: Interventional

Funder types: Industry

Identifiers

NCT00910312

AM-03

version 5.0

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

54 participants in 1 patient group

Breast Fibroadenoma

Experimental group

Treatment:

Device: Ice-Sense