Cryotherapy in Breast B3 Lesions NCT04571307

Updated 06/21/2024

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number	NCT04571307
Other study ID #	2019/2944
Secondary ID
Status	Recruiting
Phase	N/A
First received
Last updated
Start date	September 15, 2021
Est. completion date	October 15, 2022

Study information
Verified date	August 2021
Source	KK Women's and Children's Hospital
Contact	Geok Hoon Lim
Phone	96392353
Email	lim.gh[@]singhealth.com.sg
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial Summary

To determine the feasibility of cryotherapy for B3 fibroepithelial lesions

Recruitment information / eligibility
Status	Recruiting
Enrollment	12
Est. completion date	October 15, 2022
Est. primary completion date	October 15, 2022
Accepts healthy volunteers	No
Gender	Female
Age group	21 Years to 75 Years
Eligibility	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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• cryotherapy
comparison between cryotherapy and surgery

Locations
Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors *(1)*
Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of the lesion	assessed on ultrasound	2 years from procedure
Primary	breast cosmetic outcome	patient self assessment of excellent (1), good (2), fair (3) poor (4). score of 1-4,1 being the best score	at 1 year post procedure
Primary	pain score	using pain score scale of 0-10, a higher score indicates a worse outcome	immediate post procedure
Primary	pain score	using pain score scale of 0-10, a higher score indicates a worse outcome	at 2 weeks post procedure

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