Cryotherapy in Breast B3 Lesions

KK Women's and Children's Hospital

Status: Unknown

Conditions: Breast Disease; Phyllodes Breast Tumor

Treatments: Procedure: cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04571307

2019/2944

Details and patient eligibility

About

To determine the feasibility of cryotherapy for B3 fibroepithelial lesions

Enrollment: 12 estimated patients

Sex: Female

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• lesion seen on ultrasound
• core biopsy revealed FEL of B3
• lesion </+3.5cm
• keen for cryotherapy instead of surgery
• has other breast lesions for followup

Exclusion criteria

• cancer patients
• patients with bleeding diathesis
• lesions causing visible breast deformity

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)