f Post-Approval Studies (PAS) Database
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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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Post-Approval Study (2ml)

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Study Status Study Pending
Application Number /
Requirement Number
P160053 S002/ PAS001
Date Original Protocol Accepted 06/29/2023
Date Current Protocol Accepted  
Study Name Post-Approval Study (2ml)
Device Name MagtraceTM and Sentimag(R) Magnetic Locatization System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Purpose: The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration in patients who have
received Magtrace for sentinel lymph node biopsy (SLNB) and to evaluate the impact that skin discoloration has on patients when it does occur using
patient reported outcome measures.
Design: A prospective, open label study will be conducted to characterize the post-operative skin discoloration that may arise following the use of
Magtrace for sentinel lymph node biopsy in breast cancer patients undergoing lumpectomy. Patient perception will be assessed using patient
reported outcome measures.
Study Population Subjects considered for enrollment will be at least 18 years old at the time of consent, and: a) due to undergo planned breast conserving surgery (for
example lumpectomy or partial mastectomy) and SLNB with Magtrace, b) meet all other inclusion and no exclusion criteria.
Sample Size Number of subjects: 158
Assumptions for sample size estimation: A sample of 158 is expected to provide a sample of approximately 60 patients with discoloration (based on
a 38% discoloration frequency from previous data). This would provide a 95% confidence interval of ±15.65% in this scenario. With 0% at 2 years
(out of approximately 126 with follow up) the exact 95% confidence interval would be 0% to 2.9%.
Number of sites: 3
Key Study Endpoints Safety Endpoints
Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace
A. Change in BREAST-Q score from post-operative visit through to resolution of skin discoloration or through 24 months, whichever is earlier,
in the subgroup of patients with discoloration. The following core scales will be used: 1) Psychosocial well-being; 2) Sexual well-being; 3) Cancer
worry; 4) Fatigue; 5) Impact on work; 6) Physical well-being: Chest; and 7) Satisfaction with breasts.
B. Change in Breast-Q score from pre-operative visit to post-operative visit in patients with and without skin discoloration at the postoperative follow
up visit.
C. Duration of discoloration over time post-op to resolution of discoloration or 24 month follow up
D. Intensity of discoloration (absolute color and contrast to normal breast color) over time post-op to resolution of discoloration or 24mnth follow up
E. Severity of discoloration over time post-op to resolution of discoloration or 24mnth follow up as assessed by height and width measurement
F. Rates of device-related adverse events and serious device-related adverse
Follow-up Visits and Length of Follow-up Length of Follow up: Up to resolution or up to 2 years, whichever is sooner

Post-Approval Study (2ml) Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 01/01/2024   Overdue
1 year report 07/01/2024    
18 month report 01/01/2025    
2 year report 07/01/2025    
3 year report 07/01/2026    
4 year report 07/01/2027    

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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