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CRYoablation for Small Tumors As Local Treatment - SIX Trial
Sponsor: Hospital do Coracao
Summary
To demonstrate the non-inferiority of cryoablation compared to breast surgery for the local treatment of early-stage breast cancer and to conduct a cost-minimization analysis comparing direct costs between treatments.
Official title: Cryoablation Versus Breast Surgery in the Local Treatment of Early-Stage Breast Cancer - Six Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
750
Start Date
2025-03-01
Completion Date
2030-03-01
Last Updated
2025-06-26
Healthy Volunteers
No
Conditions
Interventions
cryoablation
Two devices can be used to perform cryoablation: Cryocare® and ProSense IceCure®: * Cryocare® - This procedure utilizes two types of gases: argon gas for freezing and helium gas for thawing. * ProSense IceCure® - This procedure uses extremely low temperatures generated by liquid nitrogen (LN2) to freeze and destroy the target tissue, without the need for an additional gas.
Breast Surgery (Lumpectomy or Mastectomy)
Surgery can be performed as lumpectomy or mastectomy and axillary surgery, preferably sentinel lymph node biopsy.
Locations (2)
Research Institute - Hospital do Coracao
São Paulo, São Paulo, Brazil
Research Institute - Hospital do Coracao
São Paulo, São Paulo, Brazil