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

Not Applicable

Completed

• Conditions: Breast-Conserving Surgery; Breast Cancer - Ductal Carcinoma in Situ (DCIS)
• Interventions: Device: Histolog Scanner

• Registration Number: NCT05946759
• Lead Sponsor: SamanTree Medical SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-14
• Study Start: 2023-10-10
• Status Verified: 2024-03
• Primary Completion: 2024-03-12
• Study Completion: 2024-03-12
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prospective	Histolog Scanner	50 prospective subjects

Primary Outcome Measures

Name	Time	Method
Reoperation Rate	2-30 days post Breast Surgery	Differences in the rate of reoperation due to cancer positive margins

Secondary Outcome Measures

Name	Time	Method
Change in hospital cost with or without IVD device and accessories [Economic Impact]	30 days post surgery date	To evaluate the economic impact for the hospital/payer of the reoperation rate
System Usability Scale (SUS) of the IVD device and accessories [Usability]	Only during the time of the breast surgery	To survey usability of the HLS and accessories when used intraoperatively
Incidence of adverse device effects [Safety]	Only during the time of the breast surgery	Incidence of adverse device effects during surgery
Margin status of intraoperative specimen vs. postoperative pathology assessment [Clinical Performance]	0-30 days post Breast Surgery	To observe real life clinical performance of the HLS and accessories when used intraoperatively

Trial Locations

Locations (1)

St. Vincenz-Krankenhaus GmbH, Frauenklinik St. Louise; 🇩🇪 Paderborn, Germany