Trials / Suspended
SuspendedNCT03845907
Clinical Evaluation of Opto-Acoustic Image Quality With the Gen1B Duplex Probe in Breast Applications
- Status
- Suspended
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Seno Medical Instruments Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Comparative Evaluation of Gen1B (OA-16-1S) duplex OA/US probe versus Gen1 (OA-16-1) duplex OA/US probe in Healthy Subjects
Detailed description
This study performs the first clinical evaluation of the Gen1B (OA-16-1S) duplex OA/US probe. This probe includes design changes to improve reliability and performance compared to the Gen1 (OA-16-1) duplex OA/US probe. The performance of the Gen1 duplex probe is functionally equivalent to the PIONEER duplex probe (OA-15-3), which was used in previous clinical studies for suspicious breast masses.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Gen 1B | Diagnostic Ultrasound and Optoacoustic Imaging |
| DEVICE | Gen 1 | Diagnostic Ultrasound and Optoacoustic Imaging |
Timeline
- Start date
- 2018-12-19
- Primary completion
- 2020-12-30
- Completion
- 2020-12-30
- First posted
- 2019-02-19
- Last updated
- 2020-04-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03845907. Inclusion in this directory is not an endorsement.