Real-time intraoperative margin assessment
| Pappo (Israel) | Allweis (Israel) | Thill (Germany) | Schnabel (US/Pivotal) | Columbia (Subset of Pivotal) | Sebastian (US) | Blohmer (Germany) | Coble (US) | Kupstas (US) | Gooch (US) |
|
|---|---|---|---|---|---|---|---|---|---|---|
| Purpose | Substantiate diagnostic capabilities | Israeli Pivotal Trial Intended Use | MP in pure DCIS | US Pivotal Trial FDA Approval | Compare site results in Pivotal trial vs Pivotal as a whole | Post-Market Routine Use | Routine Use with Gross Assessment | Routine Use Full Cavity Shave | Routine Use | |
| Published | J Surg Research (2010) 160, 277-281 | Am J Surg (2008) 196, 483–489 | The Breast (2014) 23, 94-96 | Ann Surg Oncol (2014) 21:1589–1595 | ASBS 2015 (Poster) | SpringerPlus (2015) 4:198 | Arch Gynecol Obstet (2016) 294(2):361-7 | Am J Surg (2017) 213, 627-630 | Am J Surg (2017) 215(3): 400-403 | Ann Surg Oncol (2019) 26:1729 |
| Study Design | Direct point by point comparison to pathology | Prospective, Double Arm, Randomized, Controlled | Prospective, Single Arm, Controlled, Comparison to Historical Control in DCIS | Prospective, Double Arm, Randomized, Controlled | Retrospective Review of Pivotal Study Data | Retrospective, Single Arm, Comparison to Historical Control | Prospective, Single Arm, Controlled, Comparison to Historical Control Gross Assessment | Retrospective, Single Arm, Comparison to Historical Control Full Cavity Shave | Retrospective, Single Arm, Comparison to Historical Control post No Tumor on Ink Guideline | Retrospective Chart Review, Single Arm |
| Number of Patients | 753 Measurements | 293 | 109 | 596 | 46 | 351 | 322 | 256 | 240 | 341 |
| Number of sites/surgeons | 3 sites | 11 sites/35 surgeons | 3 Sites/3 Surgeons | 21 Sites/53 Surgeons | 1 site/3 Surgeons | 3 sites/4 Surgeons | 1 Site/5 Surgeons | 1 Site/1 Surgeon | 1 Site/2 Surgeons | 1 Site/5 Surgeons |
| Historical Re-ex rate | N/A | 12.7% | 39% | 25.8% | 0.35 | 25.8% | 30% | 15% | 15% | N/A |
| MarginProbe Re-ex rate | N/A | 5.6% | 17% | 19.8% | 0.04 | 9.7% | 14.5% | 6.6% | 5.8% | 9.7% |
| Relative Reduction | N/A | 56% | 56% | 23% - re-ex 62% reduction positive margins | 0.885 | 62% | 52% | 56% | 61.1% | 75% reduction positive margins |
| Cosmesis or Volume Notes | N/A | Cosmesis favorable | Cosmesis 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 tissue | 32% reduction in overall tissue volume | No difference in overall tissue volume | Performance maintained regardless of density |
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