Cryoablation vs Lumpectomy in T1 Breast Cancers

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

April 3, 2024

Primary Completion Date

April 30, 2033

Study Completion Date

April 30, 2033

Conditions
Breast CancerBreast Neoplasm
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.

Trial Locations (1)

63110

RECRUITING

Washington University School of Medicine, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

The Foundation for Barnes-Jewish Hospital

OTHER

collaborator

Varian Medical Systems

INDUSTRY

lead

Washington University School of Medicine

OTHER