N/A
N=664
MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00749931 ↗Enrolled (actual)
664
Serious AEs
2.1%
Results posted
Jun 2014
Primary outcome: Primary: 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. — 22.4; 71.8 percentage of participants analyzed — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MarginProbe (Device); Lumpectomy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dune Medical Devices
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
22.4; 71.8 | <0.0001 sig |
Summary
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.
Eligibility Criteria
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
- Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
- Bilateral disease (diagnosed cancer in both breasts)
- Neoadjuvant systemic therapy
- Previous radiation in the operated breast
- Prior surgical procedure in the same breast
- Implants in the operated breast
- Pregnancy
- Lactation
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
Data sourced from ClinicalTrials.gov (NCT00749931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.