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.
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
CONTACT