Trials / Recruiting
RecruitingNCT05505643
Cryoablation vs Lumpectomy in T1 Breast Cancers
COOL-IT: Cryoablation vs Lumpectomy in T1 Breast Cancers: A Randomized Controlled Trial With Safety Lead-in
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- Female
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-04-03
- Primary completion
- 2033-04-30
- Completion
- 2033-04-30
- First posted
- 2022-08-18
- Last updated
- 2026-02-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05505643. Inclusion in this directory is not an endorsement.