MedTrace Logo

Low Energy Dissection Vs. Electrocautery in Lumpectomy Shaved Surgical Margins

NCT03718442 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2018-10-24

No results posted yet for this study

Summary

The purpose of this study is to compare the qualitative severity and depth of dissection devices' associated thermal artifact in breast lumpectomy shaved margins between the use of electrocautery and low thermal energy dissection, PhotonBlade.

The investigators hypothesize that the use of PhotonBlade would result in a significantly lower qualitative severity and a shorter depth of thermal artifact in breast lumpectomies shaved margins, when compared to electrocautery devices.

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 & Collaborators

  • Montefiore Medical Center

    collaborator OTHER

  • Invuity, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2019-12-15
Completion
2020-06-15
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03718442 on ClinicalTrials.gov