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

March 20, 2024 updated by: SamanTree Medical SA

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Paderborn, Germany
        • St. Vincenz-Krankenhaus GmbH, Frauenklinik St. Louise

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prospective
50 prospective subjects
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.
No Intervention: Historical
40 historical subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation Rate
Time Frame: 2-30 days post Breast Surgery
Differences in the rate of reoperation due to cancer positive margins
2-30 days post Breast Surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0-30 days post Breast Surgery
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
Only during the time of the breast surgery
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
30 days post surgery date
Incidence of adverse device effects [Safety]
Time Frame: Only during the time of the breast surgery
Incidence of adverse device effects during surgery
Only during the time of the breast surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SamanTree Medical SA

Collaborators

St. Vincenz Krankenhaus GmbH, Paderborn

Investigators

  • Principal Investigator: Michael P Lux, Prof. Dr MBA, St. Vincenz Krankenhaus GmbH, Paderborn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2023

Primary Completion (Actual)

March 12, 2024

Study Completion (Actual)

March 12, 2024

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHIELD (Other Identifier: Jacobs Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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