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CairnSurgical Breast Cancer Locator (BCL) Post-Market Study

NCT06461663 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-06-17

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • CairnSurgical, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Barth, MD · Cairn Surgical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-22
Primary Completion
2024-04-19
Completion
2024-04-19
FDA Device
Yes

Countries

  • Germany
  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06461663 on ClinicalTrials.gov