MedTrace Logo

Cryoablation vs Lumpectomy in T1 Breast Cancers

NCT05505643 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-02-27

No results posted yet for this study

Summary

This trial studies the efficacy and safety of cryoablation in patients with low risk, early stage breast cancer. Cryoablation is a method of killing a tumor by freezing it. The standard approach for patients with this kind of cancer is a lumpectomy. This study will review the safety of the cryoablation procedure initially, followed by comparing cryoablation to lumpectomy in order to see if the cryoablation results in better disease control, complication rates, and quality of life.

Conditions

Interventions

DEVICE

Endocare SlimLine Cryoprobe

The Endocare(TM) SlimLine (TM) Cryoprobe is a single use, disposable device designed for use with Endocare Cryocare Surgical Systems. Endocare cryoprobes are designed to deliver cold temperatures for cryoablation using high-pressure argon gas circulated through the cryoprobe, followed by active thawing using helium gas. The Cryocare CS Surgical System is intended for use in open, minimally invasive, or endoscopic surgical procedures in the areas of general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery, and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures.

PROCEDURE

Lumpectomy

Patients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.

Sponsors & Collaborators

  • The Foundation for Barnes-Jewish Hospital

    collaborator OTHER

  • Varian Medical Systems

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Heather Garrett, M.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-03
Primary Completion
2033-04-30
Completion
2033-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05505643 on ClinicalTrials.gov