Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)

Conditions

• Low-Risk, Early Stage Breast Cancer

Eligibility Criteria

Sex

ALL

Age

70 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cryoablation — DEVICE
  Cryoablation procedure, without resection, using the IceCure Medical ProSense® Cryoablation System. Patients will be also provided with adjuvant endocrine therapy for 5 years post-treatment. The IceCure ProSense® cryoablation system is intended for cryogenic destruction of tissue by the application of extreme cold temperatures.

Study Details

The FDA has granted marketing authorization for the ProSense® Cryoablation System for the local treatment of patients aged 70 years or older with low-risk early-stage breast cancer who are also receiving adjuvant hormone therapy. This clinical trial is designed to collect additional data on the safety and effectiveness of cryoablation when used as part of routine clinical care. Specifically, the study will evaluate recurrence rates following the procedure for up to 5 years post-treatment. In addition, linkage to claims data will be used to assess long-term outcomes, including breast cancer-related surgeries, mammograms and other breast imaging procedures, breast biopsies, and all-cause mortality.

Key Dates

First listed

Jun 5, 2026

Start date

Jul 17, 2026

Status verified

Sep 2026

Primary completion

Jul 31, 2034

Completion

Sep 30, 2034

Study Design

Enrollment

400 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Low-risk, Early satge breast cancer
  FDA-Approved cryoablation procedure for the indicated population

Primary Outcome Measure

Confirmed Ipsilateral Breast Tumor Recurrence (IBTR) Rate [ Time Frame: 5 Years ]

Central Contacts

• Eidan Loushi Clinical Operations Specialist, M.Sc.
  +972-548118632
  [email protected]
• Ronit Lipson, Clinical Trial Manager
  +972-522337768
  [email protected]

Locations (2)

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