An interventional study of Breast Cancer Locator Guided Breast Conserving Surgery in Breast Cancer, sponsored by CairnSurgical, Inc.. Completed at 6 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by CairnSurgical, Inc. · Not applicable, Interventional, and Treatment
This interventional, post-market, multicenter clinical investigation is designed to evaluate the performance of a custom-made medical device, "the Breast Cancer Locator (BCL)" in Subjects with non-palpable breast cancer, in Europe.
The aim of this interventional, post-market, multicenter clinical investigation is to evaluate the performance of a custom-made medical device, the Breast Cancer Locator (BCL) system, in subjects with non-palpable breast cancer. The study will be conducted in European countries. To evaluate the performance of BCL in reducing the positive margin rate, the proportion of patients with positive margins after partial mastectomy with the BCL will be obtained.
Each Subject, after signing an Informed Consent Form (ICF), will enter into a screening phase, during which several assessments (e.g., demographics, medical history, evaluation of available prone MRI and core biopsy pathological results) will be conducted.
At visit 1, the Subject will undergo supine MRI, from which a 3D breast image and BCL will be made.
At visit 2, the patient will undergo Breast Conserving Surgery (BCS) using the BCL system. On the same day, the specimen volume will be determined. The excised specimen will be sent to the pathological lab for analysis. The results, including the positive margin rate (PMR) and specimen mammogram, will be obtained within 14 days.
At visit 3, follow-up assessments (including physical examination, and adverse event review) will be performed.
At the End Of Study visit, adverse events will be assessed and patients will be asked to express their satisfaction with the BREAST-Q.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 35 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →CairnSurgical, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will undergo breast conserving surgery with the Breast Cancer Locator (BCL)
Device: Breast Cancer Locator Guided Breast Conserving Surgery
Subjects will undergo a contrast-enhanced supine MRI and two marks will be placed on the breast. The MRI images will be transmitted to the sponsor, and the images will be used to build a BCL using 3D printing. Investigators will be provided with a 3D image of the cancer in the breast. Investigators will use a BCL (a patient-specific, plastic, bra-like form that is placed on the breast and allows the investigator to mark the edges of the tumor on the skin and to place wires inside the breast which define the center of the cancer and the tumor edges. The surgeon will then attempt to surgically remove all the tissue inside the wires used to define the tumor edges.
Positive Margin Rate
To evaluate the performance of BCL in reducing the positive margin rate, the proportion of patients with positive margins after partial mastectomy with the BCL was obtained.
Time frame: Pathology results from the index procedure available within 14 days from the day of sample arrival at the pathological lab.
Specimen Volume
To calculate the specimen volume after BCL guided partial mastectomy, the water displacement method (WDM) was used.
Time frame: Results obtained the same day of surgery.
Surgeon's Perception
To evaluate the surgeon's perception of the BCL system, a survey asking them if they strongly disagree, somewhat disagree, are undecided, somewhat agree, or strongly agree that the BCL made tumor localization easier, was easy to use, made tumor excision easier, and would be recommended by them, will be used.
Time frame: Results will be obtained prior to subject discharge after the study procedure (within approximately 2 days after surgery)
Number of Participants With Adverse Events
To evaluate the safety and tolerability of BCL, adverse events will be reported, including frequency, maximum intensity, relation to study treatment, seriousness, action taken, and outcome. Safety data will be handled descriptively.
Time frame: From supine MRI 10-40 days prior to surgery through 6 weeks +/- 7 days post surgery
Patient Satisfaction
To evaluate the patient's satisfaction, the BREAST-Q patient-reported outcome measure will be used. Patient satisfaction scores range from 0-100, with a higher score meaning greater satisfaction or better quality of life.
Time frame: 6 weeks +/- 7 days post surgery
Adult women with a diagnosis by pre-operative biopsy of non-palpable breast cancer were recruited from patients at participating sites. Patients were recruited from June 2022 to May 2024.
| Milestone | Treatment With BCL |
|---|---|
| Started | 35 |
| Completed | 35 |
| Not completed | 0 |
To evaluate the performance of BCL in reducing the positive margin rate, the proportion of patients with positive margins after partial mastectomy with the BCL was obtained.
| Participants | Treatment With BCL |
|---|---|
| Positive Margin Rate | 2 |
To calculate the specimen volume after BCL guided partial mastectomy, the water displacement method (WDM) was used.
| ml | Treatment With BCL |
|---|---|
| Specimen Volume | 55.3 ± 40.2 |
To evaluate the surgeon's perception of the BCL system, a survey asking them if they strongly disagree, somewhat disagree, are undecided, somewhat agree, or strongly agree that the BCL made tumor localization easier, was easy to use, made tumor excision easier, and would be recommended by them, will be used.
| Percent of surgeon responses | Treatment With BCL |
|---|---|
| Surgeon rating of satisfied or very satisfied with the BCL device | 29 |
| Surgeon rating BCL easy or very easy | 24 |
| Surgeon rating BCL as somewhat or very much simplifying surgery | 14 |
| Surgeon rating BCL device as somewhat or very much speeding up surgery | 9 |
| Surgeon rating the BCL safety as high or very high | 29 |
| Surgeon rating BCL reliability as high or very high | 30 |
| Surgeon rating likely or very like to reuse the BCL devicehe | 24 |
| Surgeon rating likely or very likely to recommend the BCL device to a colleague | 17 |
To evaluate the safety and tolerability of BCL, adverse events will be reported, including frequency, maximum intensity, relation to study treatment, seriousness, action taken, and outcome. Safety data will be handled descriptively.
| Participants | Treatment With BCL |
|---|---|
| Participants with at least one AE | 10 |
| Participants with at least one AE related to investigational product | 3 |
| Participants with at least one SAE | 0 |
| Participants with at least 1 severe AE | 1 |
To evaluate the patient's satisfaction, the BREAST-Q patient-reported outcome measure will be used. Patient satisfaction scores range from 0-100, with a higher score meaning greater satisfaction or better quality of life.
| scores on a scale | Treatment With BCL |
|---|---|
| Patient Satisfaction | 64 ± 14 |
Collected over From supine MRI 10-40 days prior to surgery through 6 weeks +/- 7 days post surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment With BCL | 0/35 (0%) | 0/35 (0%) | 10/35 (28.6%) |
| Event | Treatment With BCL |
|---|---|
| Cancer cells presentInvestigations | 4/35 |
| PainGeneral disorders | 3/35 |
| SeromaInjury, poisoning and procedural complications | 2/35 |
| AnxietyPsychiatric disorders | 2/35 |
| Postoperative wound infectionInfections and infestations | 1/35 |
| Axillary lymphadenectomySurgical and medical procedures | 1/35 |
| Age, Continuous(years) | Treatment With BCL |
|---|---|
| Mean | 61.54 ± 11.17 |
| Sex: Female, Male(Participants) | Treatment With BCL |
|---|---|
| Female | 35 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Treatment With BCL |
|---|---|
| Caucasian | 31 |
| Asian | 1 |
| Other | 3 |
| BREAST-Q Rasch score(scores on a scale) | Treatment With BCL |
|---|---|
| Mean | 67 ± 18 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — There is no plan to share individual participant data to other researchers.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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CairnSurgical, Inc.