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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05946759
Other study ID # SHIELD
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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