title: A device for real-time, intraoperative margin assessment in breast-conservation surgery.
abstract: BACKGROUND
  This trial was designed to study performance of a novel handheld probe (Dune Medical Devices, Caesarea, Israel) in intraoperative detection of positive margins and its potential benefit toward minimizing the positive margin rate.
  
  
  METHODS
  The probe was intraoperatively applied to 57 lumpectomy specimens. Surgeons were blinded to device output, and surgical decisions were not affected by probe data. Probe readings were compared with histological analysis per margin and per patient.
  
  
  RESULTS
  Nineteen of 22 (86%) pathology-positive patients were intraoperatively detected with device use. Per-margin sensitivity was .71, and specificity was .68, maintained within a range of positive margin definitions (0-.4 cm).
  
  
  CONCLUSIONS
  The device is an effective tool for intraoperative detection of positive margins with the potential for significant positive margin rate reduction.
authors.affiliation: Breast Care Institute, Assaf Harofeh Medical Center, Zrifin Beer Yaakov, 70300, Israel. tami@karni.org
authors.forename: Tami
authors.initials: T
authors.lastname: Karni
authors.forename: Itzhak
authors.initials: I
authors.lastname: Pappo
authors.forename: Judith
authors.initials: J
authors.lastname: Sandbank
authors.forename: Oleg
authors.initials: O
authors.lastname: Lavon
authors.forename: Varda
authors.initials: V
authors.lastname: Kent
authors.forename: Rona
authors.initials: R
authors.lastname: Spector
authors.forename: Sara
authors.initials: S
authors.lastname: Morgenstern
authors.forename: Shlomo
authors.initials: S
authors.lastname: Lelcuk
mesh_terms: D000328:Adult; D001943:Breast Neoplasms / Q000473:pathology* / Q000601:surgery*; D004867:Equipment Design; D005260:Female; D006801:Humans; D007430:Intraoperative Care / Q000295:instrumentation*; D015412:Mastectomy, Segmental / Q000295:instrumentation*