Clinical trial · Interventional
A Trial of a New Magnetic Breast Marking Clip
Phase 1 Study of Magnetic Breast Marking Clip System MagneMark
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This small pilot will allow surgeons to perform wireless breast lumpectomies using a new magnetic technology. This is a continuation of a previous project testing the technology, and the breast surgeons comfort level using this new technology. The aim of this project is to develop a new technique for surgical excision of lesions either through surgical biopsy or lumpectomy. The current standard of care involves placing a needle then slender wire through the lesion under image guidance by a radiologist. The surgeon then removes the lesion using the wire as a guide. This new technique would place a magnet through the lesion under image guidance by a radiologist. The surgeon would then use the MagneProbe in the operating room to locate the magnet and remove the lesion. This new technique would eliminate the use of a wire that protrudes from a patient's breast. This wire is usually placed on the day of surgery, prior to the procedure. The goal of this new technique is to eliminate wire placement and increase patient comfort throughout the day of her surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MagneMarker | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Investigational Device
- description
- All patients will undergo breast localization and excision of a lesion using the MagneMark system. The radiologist will insert the MagneMarker clip into the area of concern using the MagneJector device. The surgeon will then locate the MagneMaker clip using the MagneProbe. The clip and breast tissue of concern will then be removed.
- interventionNames
- Device: MagneMarker
Primary outcomes (1)
- measure
- Completeness of Excision
- timeFrame
- 1 year
- description
- Investigators anticipate that cases using this localization and excision technique will be successful at minimum 96% of the time. The rate at which excision is successful using traditional methods. This outcome will be assessed and presented at the completion of the trial at the end of one year
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: i) Female ii) Ages 19-100 iii) Have a single breast lesion that has been previously biopsied and iv) Is discretely identified by: 1. A metallic biopsy site marker or 2. Ultrasound or 3. Mammography and v) Is scheduled for preoperative needle localization with a single wire and vi) Is English speaking vii) Is capable of making medical decisions, not cognitively impaired viii) Is being localized by a study radiologist or can be rescheduled to be localized by a study radiologist Exclusion Criteria: i) Cognitively impaired adults ii) Non- English speakers ii) Men
References
Publications (0)
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