Trials / Completed
CompletedNCT04242277
Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue.
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
- —
- Study type
- Observational
- Enrollment
- 198 (actual)
- Sponsor
- Perimeter Medical Imaging · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology.
Detailed description
Data collected during this study will be used for product development by the study sponsor, Perimeter Medical Imaging.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Investigational WF-OCT device | Excised lumpectomy tissue will be imaged on an investigational WF-OCT device |
Timeline
- Start date
- 2020-08-03
- Primary completion
- 2021-07-27
- Completion
- 2021-07-27
- First posted
- 2020-01-27
- Last updated
- 2023-05-19
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04242277. Inclusion in this directory is not an endorsement.