Cryoablation vs Lumpectomy in T1 Breast Cancers
COOL-IT: Cryoablation vs Lumpectomy in T1 Breast Cancers: A Randomized Controlled Trial With Safety Lead-in
Washington University School of Medicine
120 participants
Apr 3, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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.
Patients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.
Locations(1)
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NCT05505643