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

Breast-Conserving Surgery Clinical Trial

— SHIELD  

Official title:

Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment in a Single-centric PMPF Study (SHIELD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05946759
• Other study ID #: SHIELD
• Status: Completed
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: March 12, 2024

Study information

• Verified date: March 2024
• Source: SamanTree Medical SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 12, 2024
• Est. primary completion date: March 12, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast-Conserving Surgery
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating

Intervention

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

Locations

Country	Name	City	State
Germany	St. Vincenz-Krankenhaus GmbH, Frauenklinik St. Louise	Paderborn

Sponsors (2)

Lead Sponsor	Collaborator
SamanTree Medical SA	St. Vincenz Krankenhaus GmbH, Paderborn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation Rate	Differences in the rate of reoperation due to cancer positive margins	2-30 days post Breast Surgery
Secondary	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	0-30 days post Breast Surgery
Secondary	System Usability Scale (SUS) of the IVD device and accessories [Usability]	To survey usability of the HLS and accessories when used intraoperatively	Only during the time of the breast surgery
Secondary	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	30 days post surgery date
Secondary	Incidence of adverse device effects [Safety]	Incidence of adverse device effects during surgery	Only during the time of the breast surgery