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NCT Number: NCT07629206

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

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Key information

Conditions

Low-Risk, Early Stage Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of a signed and dated informed consent form.
  • Age ≥70
  • 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 positive, Progesterone receptor positive, and HER2 negative
  • Low-risk tumor biology, defined as Ki67<15% or confirmed by genomic testing. In cases where Ki67 is ≥15%, low-risk status must be confirmed by genomic testing, which will prevail.
  • Lesions must be sonographically visible at the time of treatment
  • Clinically negative lymph node (N0).

Exclusion criteria

  • Presence of lobular carcinoma.
  • Presence of microinvasion or invasive breast carcinoma with extensive intraductal component (EIC), defined as DCIS component comprising ≥25%.
  • Evidence of lymphovascular invasion.
  • Presence of multifocal and/or multicentric breast cancer.
  • Presence of multifocal suspicious calcifications.
  • Presence of inflammatory features.
  • Previous ipsilateral breast radiation
  • Neoadjuvant endocrine treatment is provided to reduce the tumor size.
  • Prior or concurrent neoadjuvant chemotherapy, biological therapy, or other targeted neo-therapies.
  • Prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer.
  • Allergy to local anesthesia.
  • Any other reason defined as inoperable declared by a physician.

Treatment and study plan

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.

Primary outcomes

  1. Confirmed Ipsilateral Breast Tumor Recurrence (IBTR) Rate

    Time frame: 5 Years

    The percentage of patients who develop confirmed Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation.

  2. Confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR) Rate

    Time frame: 5 Years

    The percentage of patients who develop confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation.

Secondary outcomes

  1. Complete Primary Tumor Ablation Rate

    Time frame: 6 Months

    The percentage of patients with complete tumor ablation, defined by adequate iceball coverage of the target tumor during the cryoablation procedure and absence of residual tumor at the 6-month follow-up.

  2. Procedure duration (minutes)

    Time frame: The day of the procedure

    Procedure duration, defined as the time from procedure initiation to procedure completion, measured in minutes

  3. Number of hospitalization days following the procedure

    Time frame: 6 Months

    Length of post-procedural hospitalization (If needed), measured as the number of days from the procedure until hospital discharge.

  4. Days to resume normal activity

    Time frame: 6 Months

    Number of days after cryoablation until return to routine daily activities, as reported by the patient.

  5. Number of procedure-related outpatient visits

    Time frame: 6 Months

    Number of procedure-related outpatient visits post the procedure, which are unplanned in the study schedule of activities

  6. Physician's satisfaction with the breast's cosmetic results

    Time frame: 6 Months

    Assessed using the Sneeuw Questionnaire, an observer-rated assessment of cosmetic changes following treatment. Items are scored on a 4-point scale ranging from 1 (None) to 4 (Severe), with the overall cosmetic result rated from 1 (Poor) to 4 (Excellent).

  7. Non-serious adverse events (related/non-related to device and procedure) and procedure-related complications.

    Time frame: 6 Months

    Number, nature, and percentage of patients with non-serious adverse events (related/nonrelated to device and procedure) and procedure-related complications up to 6 months.

  8. Local recurrence and Second primary breast cancer rates

    Time frame: 5 Years

    The percentage of patients with local breast cancer recurrence or second primary breast cancer.

  9. Patient's satisfaction with cosmetic outcomes

    Time frame: 5 Years

    Patients' satisfaction will be assessed at 6-month follow-up and subsequent visits through 5 years using the 'Satisfaction with Breasts' scale from the BREAST-Q 2.0 Patient-Reported Outcome (PRO) Breast-Conserving Surgery module. Scores are reported on a 0 (Worst) to 100 (Best) scale.

  10. Patients' Quality of life (QoL)

    Time frame: 5 Years

    Improvement or maintenance of patient's quality of life will be evaluated at 6-month follow-up and subsequent visits through 5 years, compared to baseline, using two scales from the BREAST-Q 2.0 PRO Breast-Conserving Surgery module: Physical Well-Being: Chest, and Psychosocial Well-Being. BREAST-Q has domain scores reported on a 0 (Worst) to 100 (Best) scale.

  11. Locoregional recurrence (LRR) rate

    Time frame: 5 Years

    The percentage of patients who develop locoregional recurrence within 5 years post-procedure.

  12. Disease-Free Survival (DFS) rate

    Time frame: 5 Years

    The percentage of patients without evidence of IBTR, regional, or distant breast cancer recurrence, contralateral breast cancer, or death due to breast cancer.

  13. Overall Survival (OS) rate

    Time frame: 5 Years

    The percentage of participants who did not experience death due to any cause up to 5 years.

  14. Breast cancer survival rate

    Time frame: 5 Years

    The percentage of patients who did not experience death due to breast cancer up to 5 years.

  15. Rate of discontinuation of routine follow-up procedures

    Time frame: 5 Years

    The percentage of patients who discontinue routine breast-related follow-up procedures.

  16. Serious adverse events (related/non-related to device and procedure).

    Time frame: 5 Years

    The number, nature, and percentage of patients experiencing serious adverse events (SAEs), related and non-related to the device and procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Eidan Loushi Clinical Research Associate

CONTACT

[email protected]

+972-548118632

Ronit Lipson, Clinical Trial Manager

CONTACT

[email protected]

+972-522337768

Sponsors and collaborators

Lead sponsor

IceCure Medical Ltd.

Industry

Registry information

Official study title

Post Marketing Data Collection on Use of ProSense® Cryoablation System With Adjuvant Endocrine Therapy for the Treatment of Patients With Low-Risk, Early-Stage Breast Cancer (ChoICE Trial)

Important dates

Study start
2026
Primary completion
2034
Study completion
2034
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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