Trial Outcomes & Findings for CairnSurgical Breast Cancer Locator (BCL) Post-Market Study (NCT NCT06461663)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

Pathology results from the index procedure available within 14 days from the day of sample arrival at the pathological lab.

Results posted on

2026-05-27

Participant Flow

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.

After signing the informed consent form, each subject entered a screening phase, during which several assessments (e.g., demographics, medical history, evaluation of available prone MRI and core biopsy pathological results) were conducted. Blood samples were also collect. A total of 45 patients were screened; however, 6 patients were excluded due to screening failure and 4 patients because surgery could not be performed with BCL. All remaining 35 patients were treated with BCL.

Participant milestones

Participant milestones
Measure	Treatment With BCL Subjects underwent breast conserving surgery with the Breast Cancer Locator (BCL)
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Three participants did not complete the baseline BREAST-Q Rasch score.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment With BCL n=35 Participants Subjects underwent breast conserving surgery with the Breast Cancer Locator (BCL)
Age, Continuous	61.54 years STANDARD_DEVIATION 11.17 • n=35 Participants
Sex: Female, Male Female	35 Participants n=35 Participants
Sex: Female, Male Male	0 Participants n=35 Participants
Race/Ethnicity, Customized Caucasian	31 Participants n=35 Participants
Race/Ethnicity, Customized Asian	1 Participants n=35 Participants
Race/Ethnicity, Customized Other	3 Participants n=35 Participants
BREAST-Q Rasch score	67 scores on a scale STANDARD_DEVIATION 18 • n=32 Participants • Three participants did not complete the baseline BREAST-Q Rasch score.

PRIMARY outcome

Timeframe: Pathology results from the index procedure available within 14 days from the day of sample arrival at the pathological lab.

Population: Participants analyzed were in the Per Protocol Set (PPS), which included all participants who (a) met all inclusion/exclusion criteria liable to affect the performance assessment, and (b) did not present serious deviations of the protocol that could affect efficacy. Two participants with serious deviations (BCL was not used properly) were not included in this analysis.

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.

Outcome measures

Outcome measures
Measure	Treatment With BCL n=33 Participants Subjects underwent breast conserving surgery with the Breast Cancer Locator (BCL)
Positive Margin Rate	2 Participants

SECONDARY outcome

Timeframe: Results obtained the same day of surgery.

Population: Participants analyzed were in the Full Analysis Set (FAS), which included all enrolled patients undergoing surgery with the BCL System.

To calculate the specimen volume after BCL guided partial mastectomy, the water displacement method (WDM) was used.

Outcome measures

Outcome measures
Measure	Treatment With BCL n=35 Participants Subjects underwent breast conserving surgery with the Breast Cancer Locator (BCL)
Specimen Volume	55.3 ml Standard Deviation 40.2

SECONDARY outcome

Timeframe: Results will be obtained prior to subject discharge after the study procedure (within approximately 2 days after surgery)

Population: Procedures analyzed were in the Full Analysis Set (FAS), which included all enrolled patients undergoing surgery with the BCL System.

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.

Outcome measures

Outcome measures
Measure	Treatment With BCL n=35 Participants Subjects underwent breast conserving surgery with the Breast Cancer Locator (BCL)
Surgeon's Perception Surgeon rating the BCL safety as high or very high	29 Percent of surgeon responses
Surgeon's Perception Surgeon rating BCL reliability as high or very high	30 Percent of surgeon responses
Surgeon's Perception Surgeon rating of satisfied or very satisfied with the BCL device	29 Percent of surgeon responses
Surgeon's Perception Surgeon rating BCL easy or very easy	24 Percent of surgeon responses
Surgeon's Perception Surgeon rating BCL as somewhat or very much simplifying surgery	14 Percent of surgeon responses
Surgeon's Perception Surgeon rating BCL device as somewhat or very much speeding up surgery	9 Percent of surgeon responses
Surgeon's Perception Surgeon rating likely or very like to reuse the BCL devicehe	24 Percent of surgeon responses
Surgeon's Perception Surgeon rating likely or very likely to recommend the BCL device to a colleague	17 Percent of surgeon responses

SECONDARY outcome

Timeframe: From supine MRI 10-40 days prior to surgery through 6 weeks +/- 7 days post surgery

Population: Participants analyzed were in the Full Analysis Set (FAS)/Safety Analysis Set (SAS), which included all enrolled patients undergoing surgery with the BCL System.

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.

Outcome measures

Outcome measures
Measure	Treatment With BCL n=35 Participants Subjects underwent breast conserving surgery with the Breast Cancer Locator (BCL)
Number of Participants With Adverse Events Participants with at least one AE	10 Participants
Number of Participants With Adverse Events Participants with at least one AE related to investigational product	3 Participants
Number of Participants With Adverse Events Participants with at least one SAE	0 Participants
Number of Participants With Adverse Events Participants with at least 1 severe AE	1 Participants

SECONDARY outcome

Timeframe: 6 weeks +/- 7 days post surgery

Population: Participants were in the Full Analysis Set (FAS), which included all enrolled patients undergoing surgery with the BCL System; however, four (4) participants did not complete the BREAST-Q patient reported outcome measure postoperatively.

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.

Outcome measures

Outcome measures
Measure	Treatment With BCL n=31 Participants Subjects underwent breast conserving surgery with the Breast Cancer Locator (BCL)
Patient Satisfaction	64 scores on a scale Standard Deviation 14

Adverse Events

Treatment With BCL

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment With BCL n=35 participants at risk Subjects who underwent breast conserving surgery with the Breast Cancer Locator (BCL)
General disorders Pain	8.6% 3/35 • From supine MRI 10-40 days prior to surgery through 6 weeks +/- 7 days post surgery
Infections and infestations Postoperative wound infection	2.9% 1/35 • From supine MRI 10-40 days prior to surgery through 6 weeks +/- 7 days post surgery
Injury, poisoning and procedural complications Seroma	5.7% 2/35 • From supine MRI 10-40 days prior to surgery through 6 weeks +/- 7 days post surgery
Investigations Cancer cells present	11.4% 4/35 • From supine MRI 10-40 days prior to surgery through 6 weeks +/- 7 days post surgery
Psychiatric disorders Anxiety	5.7% 2/35 • From supine MRI 10-40 days prior to surgery through 6 weeks +/- 7 days post surgery
Surgical and medical procedures Axillary lymphadenectomy	2.9% 1/35 • From supine MRI 10-40 days prior to surgery through 6 weeks +/- 7 days post surgery

Additional Information

Richard J. Barth, MD

Cairn Surgical, Inc.

Phone: 603-650-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place