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Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer

NCT04397185 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2026-01-20

No results posted yet for this study

Summary

This prospective, multicenter, 1:1 randomized, controlled trial is designed to evaluate the safety and effectiveness of the Breast Cancer Locator (BCL) in subjects with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS). Subjects will be randomized to breast conserving surgery (BCS) utilizing either the BCL or wire localization (WL) to guide surgery.

Conditions

  • Breast Cancer Female

Interventions

DEVICE

Breast Cancer Locator (BCL) guided partial mastectomy

The BCL is a patient-specific, plastic, bra-like form which is placed on the breast to localize the tumor during surgery.

DEVICE

Wire Localized (WL) partial mastectomy

Standard of care procedure

Sponsors & Collaborators

  • CairnSurgical, Inc.

    lead INDUSTRY

Principal Investigators

  • Jennifer Gass, MD · Women & Infants Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-23
Primary Completion
2025-12-09
Completion
2025-12-09
FDA Device
Yes

Countries

  • United States
  • Austria
  • Canada
  • United Kingdom

Study Locations

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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 NCT04397185 on ClinicalTrials.gov