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Completed

NCT Number: NCT05946759

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Vincenz-Krankenhaus GmbH, Frauenklinik St. Louise

Paderborn, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Histolog Scanner

Device

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

Primary outcomes

  1. Reoperation Rate

    Time frame: 2-30 days post Breast Surgery

    Differences in the rate of reoperation due to cancer positive margins

Secondary outcomes

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

    Time frame: 0-30 days post Breast Surgery

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

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

    Time frame: Only during the time of the breast surgery

    To survey usability of the HLS and accessories when used intraoperatively

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

    Time frame: 30 days post surgery date

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

  4. Incidence of adverse device effects [Safety]

    Time frame: Only during the time of the breast surgery

    Incidence of adverse device effects during surgery

Sponsors and collaborators

Lead sponsor

SamanTree Medical SA

Industry

Collaborators

  • St. Vincenz Krankenhaus GmbH, Paderborn

Registry information

Official study title

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

Acronym: SHIELD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2023
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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