35
Participants
Start Date
July 22, 2022
Primary Completion Date
April 19, 2024
Study Completion Date
April 19, 2024
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.
Agaplesion Markus Hospital, Frankfurt
Universitats Klinikum Heidelberg, Heidelberg
Humanitas Research Hospital, Milan
Ospdale Santa Chiara, Pisa
Spital Zollikerberg, Zurich
Lead Sponsor
CairnSurgical, Inc.
INDUSTRY