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Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery.

NCT05113927 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 482

Last updated 2024-12-02

No results posted yet for this study

Summary

This is a multi-center, randomized, two-arm study designed to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment.

Conditions

Interventions

DEVICE

Selene

SELENE imaging of all margins, with record of each margin assessment and an opportunity to excise tissue from the lumpectomy cavity post-imaging. The new margin will be imaged with SELENE and the surgeon will record the assessment and may take additional tissue (up to a maximum of six total shaves, including up to two shaves in each orientation) or record why no further tissue may be taken.

Sponsors & Collaborators

  • Cancer Prevention Research Institute of Texas

    collaborator OTHER

  • Proxima CRO

    collaborator INDUSTRY

  • Biostatistical Consulting, Inc.

    collaborator OTHER

  • Perimeter Medical Imaging

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-09-23
Completion
2024-10-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05113927 on ClinicalTrials.gov