Low Energy Dissection Vs. Electrocautery in Lumpectomy Shaved Surgical Margins

UnknownOBSERVATIONAL
Enrollment

20

Participants

Timeline

Start Date

March 15, 2019

Primary Completion Date

December 15, 2019

Study Completion Date

June 15, 2020

Conditions
Breast Cancer Female
Interventions
DEVICE

PhotonBlade vs Bovie for lumpectomy shaved surgical margins

For each enrolled patient, six shaved margins will be obtained (superior, inferior, medial, lateral, anterior, and posterior). For each patient, electrocautery will be used to obtain 3 of the shaved margins, and PhotonBlade to obtain the other 3 shaved margins. Once the lumpectomy site shaved margins have been obtained, the shaved surgical margins will be evaluated by a pathologist whom is blinded in regards to the dissection device that was used for each margin. The pathologist will be evaluating each shaved margin and reporting the outcomes (qualitative severity and depth of thermal artifact)

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Montefiore Medical Center

OTHER

lead

Invuity, Inc.

INDUSTRY