FindTrial
Sign In

Cryotherapy in Breast B3 Lesions

Pilot Study on the Feasibility of Cryotherapy as an Alternative Treatment for Phyllodes Tumors/Breast Fibroepithelial Lesions (FELs) Needing Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04571307
Enrollment
12
Registered
2020-10-01
Start date
2021-09-15
Completion date
2022-10-15
Last updated
2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Disease, Phyllodes Breast Tumor

Brief summary

To determine the feasibility of cryotherapy for B3 fibroepithelial lesions

Interventions

PROCEDUREcryotherapy

comparison between cryotherapy and surgery

Sponsors

KK Women's and Children's Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
recurrence of the lesion2 years from procedureassessed on ultrasound
breast cosmetic outcomeat 1 year post procedurepatient self assessment of excellent (1), good (2), fair (3) poor (4). score of 1-4,1 being the best score
pain scoreimmediate post procedureusing pain score scale of 0-10, a higher score indicates a worse outcome

Countries

Singapore

Contacts

Primary ContactGeok Hoon Lim
lim.gh@singhealth.com.sg96392353

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026