Cryotherapy in Breast B3 Lesions

August 31, 2021 updated by: KK Women's and Children's Hospital

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

To determine the feasibility of cryotherapy for B3 fibroepithelial lesions

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore
        • Recruiting
        • KK Women's and Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence of the lesion
Time Frame: 2 years from procedure
assessed on ultrasound
2 years from procedure
breast cosmetic outcome
Time Frame: at 1 year post procedure
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
pain score
Time Frame: immediate post procedure
using pain score scale of 0-10, a higher score indicates a worse outcome
immediate post procedure
pain score
Time Frame: at 2 weeks post procedure
using pain score scale of 0-10, a higher score indicates a worse outcome
at 2 weeks post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Investigators

  • Principal Investigator: Geok hoon lim, KK Women's and Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 15, 2021

Primary Completion (Anticipated)

October 15, 2022

Study Completion (Anticipated)

October 15, 2022

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

September 25, 2020

First Posted (Actual)

October 1, 2020

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/2944

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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