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In Vitro Detection of Tissue Abnormality

NCT01209182 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2022-10-03

No results posted yet for this study

Summary

Intraoperative ex-vivo use of the ClearEdge Imaging Device in Breast Conserving Surgery to image the excised tissue surgical margins. The study is designed to demonstrate reduction in the need for repeat surgeries after breast conserving surgeries by using the ClearEdge as an adjunct imaging device to the standard of care.

Conditions

  • Breast Cancer Female

Interventions

DEVICE

Testing a new device (LS BioPath TOUCH) on excised tissue

Measurements are obtained with test device on excised tissue.

Sponsors & Collaborators

  • LS BioPath

    lead INDUSTRY

Principal Investigators

  • Michael Lagios, MD · St. Mary's Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-15
Primary Completion
2011-12-13
Completion
2012-01-09
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 NCT01209182 on ClinicalTrials.gov