MarginProbe® System U.S. Post-Approval Study
Public ClinicalTrials.gov record NCT02406599. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
MarginProbe® System U.S. Post-Approval Study Protocol CP-07-001
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study objective is to determine the MarginProbe® System's diagnostic accuracy at the margin level and impact on Positive Margin\* Presence originating from the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery. \*A positive margin is defined in this study as a margin microscopically measured and reported in the histology report to have cancer within 1 mm or less of the inked surface
Study identification
- NCT ID
- NCT02406599
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 440 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2015
- Primary completion
- Aug 31, 2021
- Completion
- Oct 31, 2021
- Last update posted
- Aug 17, 2021
2015 – 2021
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | — |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| NorthShore University HealthSystem | Chicago | Illinois | 60201 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| John Hopkins Medicine | Baltimore | Maryland | 21287 | — |
| Suburban Hospital | Bethesda | Maryland | 20817 | — |
| Summit Medical Group | Berkeley Heights | New Jersey | 07922 | — |
| New Mexico University Cancer center | Albuquerque | New Mexico | 87102 | — |
| Montefiore Medical Center | New York | New York | 10461 | — |
| PinnacleHealth Cancer Institute | Harrisburg | Pennsylvania | 17109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02406599, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 17, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02406599 live on ClinicalTrials.gov.