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

Recruiting N/A Interventional Study
Low-Risk, Early Stage Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
70 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
IceCure Medical Ltd. · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Provision of a signed and dated informed consent form. 2. Age ≥70 3. Diagnosis of invasive ductal breast carcinoma (IDC) by core needle biopsy, meeting the following criteria: * Unifocal primary disease * Tumor size ≤1.5 cm in greatest diameter * Estrogen receptor p…
Contacts

Eidan Loushi Clinical Operations Specialist, M.Sc.

+972-548118632

eidanl@icecure-medical.com

CONTACT

Ronit Lipson, Clinical Trial Manager

+972-522337768

ronitl@Icecure-medical.com

CONTACT