CRYoablation for Small Tumors As Local Treatment - SIX Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Locoregional recurrence (LRR) — 5 years
  LRR was defined as recurrence in the ipsilateral breast or chest wall, as well as in the ipsilateral axillary, supraclavicular/infraclavicular region, or internal mammary lymph nodes detected during follow-up, regardless of whether distant metastasis occurred before, after, or simultaneously.
• Cost-minimization — 1 year
  A cost-minimization analysis is an economic technique used to compare the costs of different interventions or treatments that produce equivalent outcomes in terms of efficacy and clinical effects. In other words, this analysis is applied when treatments are assumed to have the same clinical effectiveness, and the goal is to determine which one has the lowest cost. It is a type of cost-effectiveness analysis that compares only the costs of two or more technologies, as the health effects resulting from the compared technologies are considered similar. Clinical outcomes will not be taken into account. We will calculate the costs by collecting data on both direct and indirect expenses associated with the treatments. Direct costs will include procedure-related expenses such as equipment, supplies, medical fees, associated tests and consultations, hospitalization costs if applicable, and medication use. Indirect costs, if a societal perspective is considered, will include factors such as ti

Trial sites (2)

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