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Efficacy of OneMark Device in Identifying Breast Cancer for Surgery and Surveillance
NCT07087691 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this research is to study a localization device for breast cancer called OneMark. This device will be studied in breast cancer surgery and during surveillance in patients being monitored for breast cancer. The main questions the study aims to answer are: Can surgeons visualize the OneMark device during breast cancer surgery better than a standard of care visualization device? Can radiologists visualize the OneMark device over time during breast cancer surveillance in patients with low or high density breast tissue? Participants will undergo breast cancer surgery or surveillance as required for their regular care. For patients undergoing surgery, the device will be implanted ahead of surgery. For patients in surveillance, the device will be implanted during biopsy and visibility of the device will be assessed by radiologists after 1, 3, and 6 months, and optionally after 12 months. Surgeons will complete a questionnaire at every surgery on the visibility of the OneMark device and the standard of care visualization device. Radiologists will complete a questionnaire after 1, 3, 6 months (and optionally after 12 months) after implantations in the patients in the surveillance program.
Conditions Studied
Interventions
- DEVICE OneMark device
Study Locations (1)
California
- University of California, San Diego — La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-12-22 |
| Est. Completion | 2028-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07087691
The ClinicalTrials.gov registry entry for NCT07087691 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 823 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention — of which OneMark device is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07087691 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07087691 about?
NCT07087691 is a clinical study titled "Efficacy of OneMark Device in Identifying Breast Cancer for Surgery and Surveillance". The goal of this research is to study a localization device for breast cancer called OneMark. This device will be studied in breast cancer surgery and during surveillance in patients being monitored for breast cancer. The main questions the study aims to answer are: Can surgeons visualize the OneM...
What is the current status of trial NCT07087691?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-12-22. Estimated completion is 2028-09.
What conditions does trial NCT07087691 study?
This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07087691?
The interventions under investigation include: OneMark device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07087691?
This trial is sponsored by University of California, San Diego, which has 823 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07087691 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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