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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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MarginProbe System US PAS

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Study Status Completed
Application Number P110014 / PAS001
Date Current Protocol Accepted 09/02/2019
Study Name MarginProbe System US PAS
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, newly enrolled, multicenter, randomized, double arm, controlled study of adjunctive use of the MarginProbe System (Standard of Care (SOC)+Device) versus standard of care, including additional inspection (SOC+Additional Inspection). The study objective is to determine the MarginProbe Systems diagnostic accuracy at the margin level and impact on Positive Margin Presence originating from the main ex-vivo lumpectomy specimen after the initial lumpectomy surgery.
Study Population Description Women histologically diagnosed with carcinoma of the breast
and women with non-palpable malignant lesions, requiring image guided localization who undergo lumpectomy (partial mastectomy) procedure.
Sample Size A total of 440 subjects with 220 in each arm.
Data Collection Co - Primary effectiveness endpoints are:
a. Sensitivity at the margin level b. Specificity at the margin level
c. Incomplete Surgical Resection (ISR) - Positive Margin on
the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery that was not addressed by taking a shaving(s) corresponding to the positive margin(s).
Secondary effectiveness endpoints are:
a. Proportion of patients with Positive Margin presence on the Outermost Shaving after the initial lumpectomy surgery (PMO)
b. Cosmesis evaluation:
- Objective evaluation by an evaluator blinded to arm assignment
- Subject's self-reported evaluation.
c. Repeat lumpectomy rate - Proportion of patients who underwent a repeat lumpectomy procedure
d. Repeat lumpectomy and mastectomy rate - Proportion of patients who underwent a repeat lumpectomy procedure or a mastectomy
e. Diagnostic Accuracy at the Patient Level (ignoring location) - Proportion of patients from whom shavings were taken
Follow-up Visits and Length of Follow-up Patients will be followed until evaluation of cosmetic status, performed at 6 +/- 1 month following the end of surgical treatment (either conversion to mastectomy, or the latest ipsilateral repeat lumpectomy procedure).
Interim or Final Data Summary
Actual Number of Patients Enrolled 438 subjects
Actual Number of Sites Enrolled 12 Enrolled Study Sites
Patient Follow-up Rate 276/438 completed follow up visit in window = 63.01%
13/438 completed follow up visit < 30 out of window = 2.97%
52/438 completed follow up 1-3 months out of window = 11.87%
70/438 completed follow up > 3 months out of window = 15.98%
411/438 completed study follow up = 93.83%
Final Safety Findings A total of 190 AEs (not including SAEs) were reported in the study, 98 (51%) within Device+SOP group and 92 (48.4%) within SOC+Additional Inspection Group. For 90 subjects AEs were reported, 48 (53%) subjects within Device+SOC group and 42 (46.7%) within SOC+Additional Inspection Group. From the 98 AEs within the Device+SOC group, 1 was classified as possible related to the device. 2 deaths occurred during this study; both unrelated to the device. Use of the MarginProbe proven safe and not associated with increased risk over Control Group.
Final Effect Findings All components of the primary endpoint met predetermined study success criteria. The Sensitivity and Specificity at Margin Level co-primary endpoints were met at 70.2% and between 47.6% (worst
case) and 48.7% (best case) respectively. These results are comparable to the 73.8% sensitivity and 45.1% specificity reported in the MarginProbe Pivotal trial. Device demonstrated decreased rates of incomplete surgical resection (ISR) compared to control arm.
Secondary endpoints:
Rate of positive margin presence on the outermost shaving after initial lumpectomy surgery (PMO), Cosmesis Blinded Evaluation, repeat lumpectomy/mastectomy rate, sensitivity, sensitivity, and Cosmesis Self Assessment. PMO endpoint met established success criteria. All other secondary endpoints demonstrated that the Device group may have qualitative non-inferiority compared to the Control group; however, these observations were not statistically significant.
Study Strengths & Weaknesses Strength: Randomized Controlled Study with comprehensive endpoints. Inclusion of evaluator and self-reported evaluation of cosmesis.
Weaknesses: Missing Data for Secondary Effectiveness Endpoints due to incomplete evaluations due to COVID19
Recommendations for Labeling Changes We recommend labelling changes to reflect the results from the primary effectiveness endpoints (i.e. sensitivity, specificity, ISR) and PMO/Cosmesis secondary endpoints.

MarginProbe System US PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 06/27/2013 06/26/2013 On Time
one year report 12/27/2013 12/23/2013 On Time
18 month report 06/27/2014 06/27/2014 On Time
two year report 12/27/2014 12/24/2014 On Time
three year report 12/27/2015 12/24/2015 On Time
42 month report 06/27/2016 06/27/2016 On Time
four year report 12/26/2016 12/22/2016 On Time
54 month report 06/27/2017 06/27/2017 On Time
five year report 12/26/2017 12/21/2017 On Time
66 month report 06/26/2018 06/27/2018 On Time
six year report 12/26/2018 12/27/2018 Overdue/Received
seven year report 12/27/2019 12/26/2019 On Time
eight year report 12/27/2020 12/23/2020 On Time
final report 04/01/2021 04/01/2021 On Time

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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