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Intraoperative Use of an Optical Coherence Tomography (OCT) Imaging System to Guide Additional Margin Cavity Shaves in Breast Conserving Surgery (BCS)

NCT04314700 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-05-26

No results posted yet for this study

Summary

Female patients undergoing a breast conserving procedure will be consented for the excised breast tissue to be imaged on an investigational OCT-based device. Additional tissue may be excised to obtain clear/negative margins based on routine standard of care tissue assessment techniques and intraoperative OCT image review.

Conditions

  • Breast Cancer Female

Interventions

DEVICE

OCT- based investigational imaging device

Excised breast lumpectomy tissue will be imaged and images reviewed on an investigational Wide-Field OCT (WF-OCT) device.

Sponsors & Collaborators

  • Perimeter Medical Imaging

    lead INDUSTRY

Principal Investigators

  • Beth DuPree, MD · Northern Arizona Healthcare

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-11
Primary Completion
2021-10-31
Completion
2021-12-07
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04314700 on ClinicalTrials.gov