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

N/A
Waitlist Available
Led By Michael Lagios, MD
Research Sponsored by LS BioPath
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients aged 25-80 who are scheduled for surgical excision of tissue.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week after surgery
Awards & highlights

Study Summary

This trial is testing whether using the ClearEdge Imaging Device during breast conserving surgery can help reduce the need for repeat surgeries.

Eligible Conditions
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
•Accuracy of LS BioPath TOUCH device compared to pathology

Trial Design

1Treatment groups
Experimental Treatment
Group I: Device image readingExperimental Treatment1 Intervention
Tissue images generated by the device are read by surgeons to determine if the tissue area under test has abnormal component or not. When Images generated by the device are read by surgeons as abnormal an additional margin of tissue is removed. The new margin is also imaged by the device to ensure complete tumor excision.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testing a new device (LS BioPath TOUCH) on excised tissue
2010
N/A
~130

Find a Location

Who is running the clinical trial?

LS BioPathLead Sponsor
1 Previous Clinical Trials
288 Total Patients Enrolled
1 Trials studying Breast Cancer
288 Patients Enrolled for Breast Cancer
Michael Lagios, MDPrincipal InvestigatorSt. Mary's Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
In Vitro Detection of Tissue Abnormality
2010. "In Vitro Detection of Tissue Abnormality". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01209182.
~8 spots leftby Apr 2025
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