CairnSurgical Breast Cancer Locator (BCL) Post-Market Study

Breast Cancer Clinical Trial

Official title: An Interventional, Post-Market Study to Evaluate the Performance of a Custom-made Medical Device, "Breast Cancer Locator (BCL)" System, in Breast-conserving Surgery (BCS)

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT06461663
• Study type: Interventional
• Source: CairnSurgical, Inc.
• Status: Completed
• Phase: N/A
• Start date: July 22, 2022
• Completion date: April 19, 2024