NCT05113927

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

A Prospective, Multi-center, Randomized, Double-arm Trial to Determine the Impact of the SELENE System on Positive Margin Rates in Breast Conservation Surgery.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 482 (actual)
• Sponsor: Perimeter Medical Imaging · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-09-23
• Completion: 2024-10-21
• First posted: 2021-11-09
• Last updated: 2024-12-02

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study