Clinical trial · Interventional
MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
NCT00749931CI-TRIAL-00014957PivotalcompletedN/AResults postedClinicalTrials.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 purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.
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 |
|---|---|---|---|
| Lumpectomy | Procedure | — | UNRESOLVED |
| MarginProbe | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- SOC
- description
- Standard of Care arm - standard of care lumpectomy procedure
- interventionNames
- Procedure: Lumpectomy
- type
- EXPERIMENTAL
- label
- Device + SOC
- description
- Use of the device in addition to the standard of care lumpectomy procedure.
- interventionNames
- Device: MarginProbe
- Procedure: Lumpectomy
Primary outcomes (1)
- measure
- The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women histologically diagnosed with carcinoma of the breast 2. Women with non-palpable malignant lesions, requiring image guided localization. 3. Undergoing lumpectomy (partial mastectomy) procedure. 4. Age 18 years or more 5. Signed ICF Exclusion Criteria: 1. Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast) 2. Bilateral disease (diagnosed cancer in both breasts) 3. Neoadjuvant systemic therapy 4. Previous radiation in the operated breast 5. Prior surgical procedure in the same breast 6. Implants in the operated breast 7. Pregnancy 8. Lactation 9. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
References
Publications (1)
- RESULTSchnabel F, Boolbol SK, Gittleman M, Karni T, Tafra L, Feldman S, Police A, Friedman NB, Karlan S, Holmes D, Willey SC, Carmon M, Fernandez K, Akbari S, Harness J, Guerra L, Frazier T, Lane K, Simmons RM, Estabrook A, Allweis T. A randomized prospective study of lumpectomy margin assessment with use of MarginProbe in patients with nonpalpable breast malignancies. Ann Surg Oncol. 2014 May;21(5):1589-95. doi: 10.1245/s10434-014-3602-0. Epub 2014 Mar 5. PMID 24595800