An interventional study of Ice-Sense3TM/ ProSenseTM in Breast Cancer, sponsored by IceCure Medical Ltd.. Completed at 19 sites in United States. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by IceCure Medical Ltd. · Not applicable, Interventional, and Treatment
To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 206 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →IceCure Medical Ltd. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:
Exclusion Criteria:
Early stage Breast cancers up to 1.5cm
Device: Ice-Sense3TM/ ProSenseTM
Local Inbreast Breast Tumor Recurrence (IBTR) Rate
6 months post cryoabltion, then annually for 5 years
Time frame: up to 5 years
Complete Primary Tumor Ablation Rate
Complete ablation of primary tumor up to 60 months after cryoablation, reported as the percentage of patients with complete tumor ablation.
Time frame: up to 5 years from procedure date.
Improvement or Maintenance of Subject's Quality of Life
Quality of life will be assessed using the NCCN Distress Thermometer, a 0-10 scale measuring patient distress (0 = no distress, 10 = extreme distress; higher scores indicate worse distress), collected at baseline and at 6 months follow-up visit.
Time frame: Baseline and 6 months
Breast Cosmetics Satisfaction
Participants and treating physicians rated satisfaction with cosmetic outcomes following breast cryoablation.
Time frame: Up to 5 years following procedure
Regional Recurrence Rate
Regional Invasive breast tumor recurrence rate.
Time frame: up to 5 years following procedure
Distant Metastases Survival Rate
Distant metastases survival rate, including contralateral Breast cancer
Time frame: up to 5 years following procedure
Disease-free Survival (DFS)
DFS from the date of complete ablation of the primary tumor until the first disease event, where the disease event is defined as local (DCIS or invasive), regional, or distant breast cancer recurrence, or DCIS or invasive contralateral breast cancer.
Time frame: up to 5 years
Overall Survival
Overall survival from the date of the cryoablation until the date of death from any cause or up to the 60 months follow up visit
Time frame: up to 5 years
Breast Cancer Survival.
Breast Cancer Survival from the date of cryoablation until the date of death from breast cancer or up to the 60 months follow-up visit.
Time frame: up to 5 years
The study was conducted at 19 sites in the USA. All study investigators had related experience in low-risk breast cancer treatment, imaging, and pathology assessments and were trained to perform the cryoablation procedure. The recruitment period lasted from October 2014 to February 2019.
| Milestone | Single Arm, Open Label |
|---|---|
| Started | 206 |
| Per-protocol study population | 194 |
| Completed | 131 |
| Not completed | 75 |
| Withdrew: Excluded | 12 |
| Withdrew: Death | 21 |
| Withdrew: Withdrawal by subject | 22 |
| Withdrew: Lost to follow-up | 13 |
| Withdrew: Physician decision | 5 |
| Withdrew: Adverse event | 2 |
6 months post cryoabltion, then annually for 5 years
| Percentage of participants with IBTR | Single Arm, Open Label |
|---|---|
| Local Inbreast Breast Tumor Recurrence (IBTR) Rate | 4.3 (2.1 to 8.7) |
Complete ablation of primary tumor up to 60 months after cryoablation, reported as the percentage of patients with complete tumor ablation.
| Percentage of participants | Single Arm, Open Label |
|---|---|
| Complete Primary Tumor Ablation Rate | 95.7 (92.2% to —) |
Quality of life will be assessed using the NCCN Distress Thermometer, a 0-10 scale measuring patient distress (0 = no distress, 10 = extreme distress; higher scores indicate worse distress), collected at baseline and at 6 months follow-up visit.
| scores on a scale | Single Arm, Open Label |
|---|---|
| Improvement or Maintenance of Subject's Quality of Life | -0.7 ± 2.9 |
Participants and treating physicians rated satisfaction with cosmetic outcomes following breast cryoablation.
| Percentage of participants | Single Arm, Open Label |
|---|---|
| Breast Cosmetics Satisfaction | 100 |
Regional Invasive breast tumor recurrence rate.
| Percentage of participants | Single Arm, Open Label |
|---|---|
| Regional Recurrence Rate | 0 |
Distant metastases survival rate, including contralateral Breast cancer
| Percentage of participants | Single Arm, Open Label |
|---|---|
| Distant Metastases Survival Rate | 96.4 (92.2 to 98.4) |
DFS from the date of complete ablation of the primary tumor until the first disease event, where the disease event is defined as local (DCIS or invasive), regional, or distant breast cancer recurrence, or DCIS or invasive contralateral breast cancer.
| Percentage of participants | Single Arm, Open Label |
|---|---|
| Disease-free Survival (DFS) | 92.8 (87.6 to 95.8) |
Overall survival from the date of the cryoablation until the date of death from any cause or up to the 60 months follow up visit
| Percentage of participants | Single Arm, Open Label |
|---|---|
| Overall Survival | 88.6 (82.9 to 92.5) |
Breast Cancer Survival from the date of cryoablation until the date of death from breast cancer or up to the 60 months follow-up visit.
| Percentage of participants | Single Arm, Open Label |
|---|---|
| Breast Cancer Survival. | 96.7 (92.2 to 98.6) |
Collected over Adverse events were collected through 2 years post-procedure, and serious adverse events (SAEs) were collected through the final follow-up (5 years post-procedure).. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm, Open Label | 21/206 (10.2%) | 0/206 (0%) | 97/206 (47.1%) |
| Event | Single Arm, Open Label |
|---|---|
| BruisingInjury, poisoning and procedural complications | 61/206 |
| PainGeneral disorders | 39/206 |
| Localized EdemaGeneral disorders | 39/206 |
| Injection site reactionGeneral disorders | 10/206 |
| HematomaVascular disorders | 9/206 |
| Frost InjuryInjury, poisoning and procedural complications | 5/206 |
| Rash & PruritusSkin and subcutaneous tissue disorders | 4/206 |
The primary analysis set includes 194 subjects (following the DSMB exclusion of 12 subjects).
| Age, Continuous(years) | Single Arm, Open Label |
|---|---|
| Mean | 74.9 ± 6.9 |
| Sex: Female, Male(Participants) | Single Arm, Open Label |
|---|---|
| Female | 194 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Single Arm, Open Label |
|---|---|
| Ethnicity — African American | 14 |
| Ethnicity — Asian | 1 |
| Ethnicity — Caucasian | 160 |
| Ethnicity — Hispanic | 12 |
| Ethnicity — Native American | 2 |
| Ethnicity — Unknow | 5 |
| Region of Enrollment(participants) | Single Arm, Open Label |
|---|---|
| United States | 194 |
| Type of Tumor(Participants) | Single Arm, Open Label |
|---|---|
| Lumina A | 188 |
| Lumina B | 3 |
| Not specified | 3 |
| ER (Estrogen Receptor)(Participants) | Single Arm, Open Label |
|---|---|
| Positive | 194 |
| Negative | 0 |
| PR (Progesterone Receptor)(Participants) | Single Arm, Open Label |
|---|---|
| Positive | 180 |
| Negative | 14 |
| Her2neu(Participants) | Single Arm, Open Label |
|---|---|
| Positive | 0 |
| Negative | 194 |
1 further baseline measures are reported on the registry.
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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