N/A N=35 Treatment

CairnSurgical Breast Cancer Locator (BCL) Post-Market Study

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT06461663 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2026

Primary outcome: Primary: Positive Margin Rate — 2 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Breast Cancer Locator Guided Breast Conserving Surgery (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: CairnSurgical, Inc.
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Positive Margin Rate	2	—
SECONDARY Specimen Volume	55.3	—
SECONDARY Surgeon's Perception	29; 24; 14; 9; 29; 30	—
SECONDARY Number of Participants With Adverse Events	10; 3; 0; 1	—
SECONDARY Patient Satisfaction	64	0.58

Summary

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.

Eligibility Criteria

Inclusion Criteria

Patient Informed consent form (ICF) signed
Female Aged ≥ 18 years at the time of the signature of ICF
Histologic diagnosis of IBC or DCIS
Tumor excision that will require localization because it cannot be definitively defined by palpation
The tumor is unifocal; possible satellite lesions 32 cm as measured in a sitting or standing position
Measurement of widest circumference around breasts and arms > 135 cm
Known allergy to device components
Multicentric tumors (additional tumors > 2 cm from primary)
Infectious or inflammatory processes near the area of intervention
Planned surgery with localization devices including WGL, intraoperative ultrasound guidance, radiofrequency emitting implants, magnetic seeds, radioactive seeds, and tissue inspection devices
Simultaneous participation in an interventional study or participation in an interventional study in the last 1 month before study inclusion
Known drug and/or alcohol abuse
Mental incapacity that precludes adequate understanding or cooperation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06461663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.