Clinical Data

Real-time intraoperative margin assessment

(Subset of Pivotal)
PurposeSubstantiate diagnostic capabilitiesIsraeli Pivotal Trial
Intended Use
MP in pure DCISUS Pivotal Trial
FDA Approval
Compare site results in Pivotal trial vs Pivotal as a wholePost-Market
Routine Use
Routine Use with Gross AssessmentRoutine Use
Full Cavity Shave
Routine Use
PublishedJ Surg Research (2010)
160, 277-281
Am J Surg (2008)
196, 483–489
The Breast (2014)
23, 94-96
Ann Surg Oncol (2014)
ASBS 2015
SpringerPlus (2015)
Arch Gynecol Obstet (2016)
Am J Surg (2017)
213, 627-630
Am J Surg (2017)
215(3): 400-403
Ann Surg Oncol (2019) 26:1729
Study DesignDirect point by point comparison to pathologyProspective, Double Arm, Randomized, ControlledProspective, Single Arm, Controlled, Comparison to Historical Control in DCISProspective, Double Arm, Randomized, ControlledRetrospective Review of Pivotal Study DataRetrospective, Single Arm, Comparison to Historical ControlProspective, Single Arm, Controlled, Comparison to Historical Control Gross AssessmentRetrospective, Single Arm, Comparison to Historical Control Full Cavity Shave Retrospective, Single Arm, Comparison to Historical Control post No Tumor on Ink GuidelineRetrospective Chart Review, Single Arm
Number of Patients753 Measurements29310959646351322256240341
Number of sites/surgeons3 sites11 sites/35 surgeons3 Sites/3 Surgeons21 Sites/53 Surgeons1 site/3 Surgeons3 sites/4 Surgeons1 Site/5 Surgeons1 Site/1 Surgeon1 Site/2 Surgeons1 Site/5 Surgeons
Historical Re-ex rateN/A12.7%39%25.8%0.3525.8%30%15%15%N/A
MarginProbe Re-ex rateN/A5.6%17%19.8%0.049.7%14.5%6.6%5.8%9.7%
Relative ReductionN/A56%56%23% - re-ex
62% reduction positive margins
0.88562%52%56%61.1%75% reduction positive margins
Cosmesis or Volume NotesN/ACosmesis favorableCosmesis Favorable Thin margin shavings resulted in high number of identified margins remaining positive despite significant MP performance
8-10cc additional tissue volume
Consistent performance across all historical re-ex rates
44-17% = 61%
30-10% = 67%
16-8% = 50%
12-4% = 67%
No difference in overall volume tissue32% reduction in overall tissue volumeNo difference in overall tissue volumePerformance maintained regardless of density

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