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

Primary Purpose

Breast Cancer - Ductal Carcinoma in Situ (DCIS), Breast-Conserving Surgery

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Histolog Scanner
Sponsored by
SamanTree Medical SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer - Ductal Carcinoma in Situ (DCIS) focused on measuring Reoperation Rate, Breast Conserving Surgery, Confocal laser scanning microscope, Confocal microscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Prospective

Historical

Arm Description

50 prospective subjects

40 historical subjects

Outcomes

Primary Outcome Measures

Reoperation Rate
Differences in the rate of reoperation due to cancer positive margins

Secondary Outcome Measures

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
System Usability Scale (SUS) of the IVD device and accessories [Usability]
To survey usability of the HLS and accessories when used intraoperatively
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
Incidence of adverse device effects [Safety]
Incidence of adverse device effects during surgery

Full Information

First Posted
June 27, 2023
Last Updated
October 23, 2023
Sponsor
SamanTree Medical SA
Collaborators
St. Vincenz Krankenhaus GmbH, Paderborn
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1. Study Identification

Unique Protocol Identification Number
NCT05946759
Brief Title
Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment
Acronym
SHIELD
Official Title
Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment in a Single-centric PMPF Study (SHIELD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 10, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SamanTree Medical SA
Collaborators
St. Vincenz Krankenhaus GmbH, Paderborn

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer - Ductal Carcinoma in Situ (DCIS), Breast-Conserving Surgery
Keywords
Reoperation Rate, Breast Conserving Surgery, Confocal laser scanning microscope, Confocal microscopy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prospective
Arm Type
Active Comparator
Arm Description
50 prospective subjects
Arm Title
Historical
Arm Type
No Intervention
Arm Description
40 historical subjects
Intervention Type
Device
Intervention Name(s)
Histolog Scanner
Intervention Description
The PMPF study is collecting data that includes the use of the CE Mark IVD Histolog Scanner for the breast lumpectomy margin assessment.
Primary Outcome Measure Information:
Title
Reoperation Rate
Description
Differences in the rate of reoperation due to cancer positive margins
Time Frame
2-30 days post Breast Surgery
Secondary Outcome Measure Information:
Title
Margin status of intraoperative specimen vs. postoperative pathology assessment [Clinical Performance]
Description
To observe real life clinical performance of the HLS and accessories when used intraoperatively
Time Frame
0-30 days post Breast Surgery
Title
System Usability Scale (SUS) of the IVD device and accessories [Usability]
Description
To survey usability of the HLS and accessories when used intraoperatively
Time Frame
Only during the time of the breast surgery
Title
Change in hospital cost with or without IVD device and accessories [Economic Impact]
Description
To evaluate the economic impact for the hospital/payer of the reoperation rate
Time Frame
30 days post surgery date
Title
Incidence of adverse device effects [Safety]
Description
Incidence of adverse device effects during surgery
Time Frame
Only during the time of the breast surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P Lux, Prof. Dr MBA
Organizational Affiliation
St. Vincenz Krankenhaus GmbH, Paderborn
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincenz-Krankenhaus GmbH, Frauenklinik St. Louise
City
Paderborn
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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