Trials / Completed
CompletedNCT05084729
CONFIDENCE Registry
A Multi-Center InternatiONal Registry to Evaluate the Efficacy oF Imaging With Opto-acoustics to Diagnose BrEast CaNCEr
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 165 (actual)
- Sponsor
- Seno Medical Instruments Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This registry has been designed to obtain real-life, post-market data on the use of the Imagio breast imaging system. This registry is sponsored by Seno Medical Instruments, Inc., the manufacturer of the device.
Detailed description
This is a prospective, controlled, multi-center, observational international registry designed to evaluate the Imagio breast imaging system. The registry will be conducted at up to 12 international centers. Investigators will use Imagio US (IUS) and/or Imagio OA/US imaging per standard of care, anddata will be collected accordingly. Additional imaging and biopsy/surgery will be conducted per standard of care to reach a final diagnosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Imagio OA/US | Imagio optoacoustic |
Timeline
- Start date
- 2020-09-11
- Primary completion
- 2023-07-19
- Completion
- 2023-07-19
- First posted
- 2021-10-20
- Last updated
- 2023-10-10
Locations
3 sites across 1 country: Netherlands
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05084729. Inclusion in this directory is not an endorsement.