search
Back to results

Cryotherapy in Breast B3 Lesions

Primary Purpose

Breast Disease, Phyllodes Breast Tumor

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
cryotherapy
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Disease

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • KK Women's and Children's HospitalRecruiting

Outcomes

Primary Outcome Measures

recurrence of the lesion
assessed on ultrasound
breast cosmetic outcome
patient self assessment of excellent (1), good (2), fair (3) poor (4). score of 1-4,1 being the best score
pain score
using pain score scale of 0-10, a higher score indicates a worse outcome
pain score
using pain score scale of 0-10, a higher score indicates a worse outcome

Secondary Outcome Measures

Full Information

First Posted
August 31, 2020
Last Updated
August 31, 2021
Sponsor
KK Women's and Children's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04571307
Brief Title
Cryotherapy in Breast B3 Lesions
Official Title
Pilot Study on the Feasibility of Cryotherapy as an Alternative Treatment for Phyllodes Tumors/Breast Fibroepithelial Lesions (FELs) Needing Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2021 (Anticipated)
Primary Completion Date
October 15, 2022 (Anticipated)
Study Completion Date
October 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To determine the feasibility of cryotherapy for B3 fibroepithelial lesions

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Disease, Phyllodes Breast Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
cryotherapy
Intervention Description
comparison between cryotherapy and surgery
Primary Outcome Measure Information:
Title
recurrence of the lesion
Description
assessed on ultrasound
Time Frame
2 years from procedure
Title
breast cosmetic outcome
Description
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
Title
pain score
Description
using pain score scale of 0-10, a higher score indicates a worse outcome
Time Frame
immediate post procedure
Title
pain score
Description
using pain score scale of 0-10, a higher score indicates a worse outcome
Time Frame
at 2 weeks post procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geok Hoon Lim
Phone
96392353
Email
lim.gh@singhealth.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geok hoon lim
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geok H Lim
Phone
+6596392353
Ext
+6596392353
Email
lim.gh@singhealth.com.sg

12. IPD Sharing Statement

Learn more about this trial

Cryotherapy in Breast B3 Lesions

We'll reach out to this number within 24 hrs