Clinical trial · Interventional
MarginProbe® System U.S. Post-Approval Study
MarginProbe® System U.S. Post-Approval Study Protocol CP-07-001
NCT02406599CI-TRIAL-00053358unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
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
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control: Additional inspection | Other | — | UNRESOLVED |
| Margin Probe | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- SOC + Device
- description
- The surgeon will perform routine standard of care lumpectomy with adjunctive MarginProbe device use on the main ex-vivo lumpectomy specimen.
- interventionNames
- Device: Margin Probe
- type
- OTHER
- label
- SOC + Additional Inspection
- description
- The surgeon will perform routine standard of care lumpectomy with additional inspection on the main ex-vivo lumpectomy specimen.
- interventionNames
- Other: Control: Additional inspection
Primary outcomes (2)
- measure
- Diagnostic accuracy at the margin level
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women histologically diagnosed with carcinoma of the breast * Women with non-palpable malignant lesions, requiring image guided localization. * Undergoing lumpectomy (partial mastectomy) procedure * Age 18 years or more * Signed ICF Exclusion Criteria: * Multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast) * Bilateral disease (diagnosed cancer in both breasts) * Neo-adjuvant systemic therapy * Previous radiation in the operated breast * Prior surgery in the same site in the breast * Woman histologically diagnosed by an open biopsy procedure * Implants in the operated breast * Pregnancy * Lactation * Participating in any other investigational study for either drug or device which could influence collection of valid data under this study * Patients for whom complete cavity shaving is planned (sites where this is the routine practice of the investigator will also be excluded from participation in the study)
References
Publications (0)
Data not yet available
No reference posted for this study.