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ClearEdge Device for Breast Cancer Surgery

N/A
Recruiting
Led By Jasmine Wong, 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 diagnosed with breast DCIS or invasive cancer recommended for lumpectomy procedure
Patients aged above 18 years, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within weeks post-op
Awards & highlights

Study Summary

This trial will assess if a new imaging device can improve accuracy of cancer removal in breast conserving surgeries and reduce the need for repeat surgeries.

Who is the study for?
This trial is for women over 18 with breast DCIS or invasive cancer who are recommended for a lumpectomy. It's not open to those who've had previous surgery or radiation on the same breast, are pregnant or breastfeeding, currently on chemotherapy, have implants, or were in another surgical breast cancer study recently.Check my eligibility
What is being tested?
The trial is testing if using the ClearEdge device during surgery helps doctors better detect and remove all of the cancer compared to standard care. This could potentially reduce the need for additional surgeries. Participants will be randomly assigned to either use this device or follow usual procedures.See study design
What are the potential side effects?
Since this trial involves a diagnostic device used during surgery rather than a drug, typical medication side effects aren't expected. However, there may be risks associated with its use during an operation that will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with breast cancer and recommended for a lumpectomy.
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I am 18 years old or older.
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I have received hormone therapy before surgery for my cancer.
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I am genetically female.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~in the operating room compared to pathology assessment within 1 week post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and in the operating room compared to pathology assessment within 1 week post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of subjects with positive margins post-op
Secondary outcome measures
FN and FP rates

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SoC+ClearEdge device - Standard of Care + study deviceExperimental Treatment1 Intervention
Standard assessment of the surgical margins of the excised breast specimen during lumpectomy surgery plus the use of the study device to assess for breast cancer cells at the the margins
Group II: SoC - Standard of CareActive Control1 Intervention
Standard assessment of the surgical margins of the excised breast specimen during lumpectomy surgery

Find a Location

Who is running the clinical trial?

LS BioPathLead Sponsor
1 Previous Clinical Trials
121 Total Patients Enrolled
Jasmine Wong, MDPrincipal InvestigatorUniversity of California, San Francisco Medical Center

Media Library

SoC+ClearEdge device - Standard of Care + study device Clinical Trial Eligibility Overview. Trial Name: NCT05456373 — N/A
Breast Cancer Research Study Groups: SoC - Standard of Care, SoC+ClearEdge device - Standard of Care + study device
Breast Cancer Clinical Trial 2023: SoC+ClearEdge device - Standard of Care + study device Highlights & Side Effects. Trial Name: NCT05456373 — N/A
SoC+ClearEdge device - Standard of Care + study device 2023 Treatment Timeline for Medical Study. Trial Name: NCT05456373 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently involved in this research protocol?

"Affirmative. According to the information listed on clinicaltrials.gov, this particular experiment is in need of participants; having been first posted November 18th 2022 and last amended March 14th 2023. It seeks 288 individuals from a single site."

Answered by AI

Are there still opportunities for volunteers to join this experiment?

"Agreed. According to clinicaltrials.gov, this research program is actively searching for participants and was originally posted on November 18th 2022 with the date of most recent update being March 14th 2023. The trial requires 288 patients from a single site to reach its enrollment goal."

Answered by AI
~65 spots leftby Aug 2024