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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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1ml Magtrace w Sentimag PAS


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General
Study Status Study Pending
Application Number /
Requirement Number
P160053 S009/ PAS001
Date Original Protocol Accepted 06/07/2024
Date Current Protocol Accepted 06/07/2024
Study Name 1ml Magtrace w Sentimag PAS
Device Name Magtrace and Sentimag Magnetic Localization 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 Transit. Adolescent B (as adults) : 18-21 yrs, 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: 184
Assumptions for sample size estimation: A sample of 184 (100 for Subareolar and 84 for peritumoral) is expected to provide a sample of approximately 70 (60 for subareolar and 10 for peritumoral) patients with discoloration.
Number of sites: 3-8
Key Study Endpoints Safety Endpoints
Primary:
Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-sample.
Secondary:
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 events
Follow-up Visits and Length of Follow-up Frequency (All patients): Visit 1 Pre-op, Visit 2 Post-op.
For patients without discoloration: Visit 3 at 12 months.
For patients with discoloration: Visit 3-6 every 6 months.
Length of Follow up: Up to resolution or up to 2 years, whichever is sooner.


1ml Magtrace w Sentimag PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/15/2024 11/04/2024 Overdue/Received
1 year report 04/15/2025    
18 month report 10/15/2025    
2 year report 04/15/2026    
3 year report 04/15/2027    


Contact Us

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

Additional Resources

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