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Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)

NCT01699867 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2015-01-06

Study results available
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Summary

This multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion criteria. The study period per subject was the time it took to assess the ex vivo breast tissue sample using the study device. Image review was conducted after surgery and compared to the margin status findings in the post-operative pathology report.

Conditions

Interventions

DEVICE

Optical coherence tomography

Optical coherence tomography was used to image ex vivo breast tissue specimens.

Sponsors & Collaborators

Principal Investigators

  • Lisa K Jacobs, M.D. · Johns Hopkins University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-05-31
Completion
2014-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT01699867 on ClinicalTrials.gov