N/A
Completed N=120
Magseed Magnetic Marker Localization
Disorders of Breast · Breast Lesions
Source: ClinicalTrials.gov NCT03020888 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Percent of Participants With Retrieval of Index Lesion and Magseed — 100 percentage of participants
Summary
The purpose of this post-marketing study is to provide prospective evidence that the Magseed and Sentimag® is effective for lesion localization in patients undergoing surgical excision of a breast lesion and to summarize measures of product safety and performance.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With Retrieval of Index Lesion and Magseed |
100 | — |
| SECONDARY Number of Device Related Adverse Events |
— | — |
| SECONDARY Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy |
98 | — |
| SECONDARY Percentage of Markers With Radiological Placement Accuracy Measured as <5mm to Lesion |
95.16 | — |
| SECONDARY Percentage of Participants With Re-excision |
9 | — |
| SECONDARY Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy |
86.9 | — |
| SECONDARY Surgical Localization - Duration of Localization |
5 | — |
| SECONDARY Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy |
96 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with a breast lesion requiring image-guided localization prior to excision.
- Subjects aged 18 years or more at the time of consent.
Exclusion Criteria
- The subject is pregnant or lactating.
- Subject has pacemaker or other implantable device in the chest wall.
- Subject has current active infection at the implantation site in the breast (per investigatordiscretion)
Data sourced from ClinicalTrials.gov (NCT03020888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.