CairnSurgical Breast Cancer Locator (BCL) Post-Market Study

NACompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

July 22, 2022

Primary Completion Date

April 19, 2024

Study Completion Date

April 19, 2024

Conditions
Breast Cancer
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.

Trial Locations (5)

60431

Agaplesion Markus Hospital, Frankfurt

Unknown

Universitats Klinikum Heidelberg, Heidelberg

Humanitas Research Hospital, Milan

Ospdale Santa Chiara, Pisa

Spital Zollikerberg, Zurich

Sponsors
All Listed Sponsors
lead

CairnSurgical, Inc.

INDUSTRY