Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment (SHIELD)

SamanTree Medical

Status

Completed

Conditions

Breast Cancer - Ductal Carcinoma in Situ (DCIS)

Breast-Conserving Surgery

Treatments

Device: Histolog Scanner

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT05946759

SHIELD

Details and patient eligibility

About

This PMPF study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when including the use of the HLS in the context of breast lumpectomy margin assessment.

Enrollment

54 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult female Subject ≥18 years old.
Subject Scheduled for breast conserving surgery of invasive and/or in-situ ductal carcinoma.
Subject is able to read, understand and sign the informed consent.

Exclusion criteria

Subject previously treated for ipsilateral breast cancer and/or ductal carcinoma in situ surgery.
Subject with previous radiotherapy of the ipsilateral breast.
Subject with multicentric/multilateral breast cancer.
Subject with planned mastectomy, tumor-adapted breast reduction.
Subject with pre-surgical/ preoperative neo-adjuvant treatment.
Subject is pregnant/ lactating.
Participation in any other clinical study that would affect data acquisition.