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

SamanTree Medical SA54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Breast Cancer - Ductal Carcinoma in Situ (DCIS)Breast-Conserving Surgery

Interventions

Histolog ScannerDEVICE

The PMPF study is collecting data that includes the use of the CE Mark IVD Histolog Scanner for the breast lumpectomy margin assessment.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

St. Vincenz-Krankenhaus GmbH, Frauenklinik St. Louise

Paderborn, Germany

Outcomes

Primary Outcomes

Reoperation Rate

Differences in the rate of reoperation due to cancer positive margins

Time frame: 2-30 days post Breast Surgery

Secondary Outcomes

Margin status of intraoperative specimen vs. postoperative pathology assessment [Clinical Performance]

To observe real life clinical performance of the HLS and accessories when used intraoperatively

Time frame: 0-30 days post Breast Surgery

System Usability Scale (SUS) of the IVD device and accessories [Usability]

To survey usability of the HLS and accessories when used intraoperatively

Time frame: Only during the time of the breast surgery

Change in hospital cost with or without IVD device and accessories [Economic Impact]

To evaluate the economic impact for the hospital/payer of the reoperation rate

Time frame: 30 days post surgery date

Incidence of adverse device effects [Safety]

Incidence of adverse device effects during surgery

Time frame: Only during the time of the breast surgery

Data from ClinicalTrials.gov

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