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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-MarginProbe System US PAS

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Application Number P110014 / PAS001
Current Plan Approved 04/29/2014
Study Name OSB Lead-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 System¿s 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).

OSB Lead-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    
five year report 12/26/2017    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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