120
Participants
Start Date
April 3, 2024
Primary Completion Date
April 30, 2033
Study Completion Date
April 30, 2033
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."
Lumpectomy
Patients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.
RECRUITING
Washington University School of Medicine, St Louis
Collaborators (1)
The Foundation for Barnes-Jewish Hospital
OTHER
Varian Medical Systems
INDUSTRY
Washington University School of Medicine
OTHER