Cryotherapy in Breast B3 Lesions

N/AUnknownNCT04571307

KK Women's and Children's Hospital12 enrolled

Overview

To determine the feasibility of cryotherapy for B3 fibroepithelial lesions

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Disease Phyllodes Breast Tumor

Interventions

cryotherapyPROCEDURE

comparison between cryotherapy and surgery

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

KK Women's and Children's Hospital

Singapore, Singapore

RECRUITING

Outcomes

Primary Outcomes

recurrence of the lesion

assessed on ultrasound

Time frame: 2 years from procedure

breast cosmetic outcome

patient self assessment of excellent (1), good (2), fair (3) poor (4). score of 1-4,1 being the best score

Time frame: at 1 year post procedure

pain score

using pain score scale of 0-10, a higher score indicates a worse outcome

Time frame: immediate post procedure

pain score

using pain score scale of 0-10, a higher score indicates a worse outcome

Time frame: at 2 weeks post procedure

Central Contacts

Geok Hoon Lim

CONTACT

96392353 lim.gh@singhealth.com.sg

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.