CRYoablation for Small Tumors As Local Treatment - SIX Trial

PHASE3RecruitingINTERVENTIONAL
Enrollment

750

Participants

Timeline

Start Date

March 1, 2025

Primary Completion Date

March 1, 2027

Study Completion Date

March 1, 2030

Conditions
Breast CancerBreast Neoplasm
Interventions
PROCEDURE

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."

PROCEDURE

Breast Surgery (Lumpectomy or Mastectomy)

Surgery can be performed as lumpectomy or mastectomy and axillary surgery, preferably sentinel lymph node biopsy.

Trial Locations (2)

04004-030

NOT_YET_RECRUITING

Research Institute - Hospital do Coracao, São Paulo

04041-004

RECRUITING

Research Institute - Hospital do Coracao, São Paulo

All Listed Sponsors
lead

Hospital do Coracao

OTHER