In Vitro Detection of Tissue Abnormality

NCT01209182 | Completed FDA Device

• 1 other identifier: LSB-01
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• •Accuracy of LS BioPath TOUCH device compared to pathology

  Assess percentage of FP and FN of test device results compared to pathology results

  1 week after surgery

Study Arms (1)

Device image reading

EXPERIMENTAL

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.

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

Interventions

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

Measurements are obtained with test device on excised tissue.

Device image reading

Eligibility Criteria

• Age: 25 Years - 80 Years
• Gender Eligibility Details: biologic females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 25-80 who are scheduled for surgical excision of tissue.

You may not qualify if:

• No prior history of surgery at location of current surgery.

Sponsors & Collaborators

• LS BioPath: lead

Study Sites (1)

St. Mary's

San Francisco, California, 94117, United States

Location

Study Officials

• Michael Lagios, MD

  St. Mary's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 phase study: Phase 1 - Validation of safety and accuracy when used ex-vivo to image excised breast surgery specimens Phase 2 - To guide surgeon's decision to re-excise additional margins during primary operation

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 27, 2010
• Study Start: October 15, 2010
• Primary Completion: December 13, 2011
• Study Completion: January 9, 2012
• Last Updated: October 3, 2022

Record last verified: 2022-04

Locations

US (1)