Trials / Terminated
TerminatedNCT03915717
Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 14 (actual)
- Sponsor
- Sonavex, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
The purpose of this study is to evaluate the performance of the EchoMark and EchoSure as an ultrasound-based method of monitoring the viability of free flaps and patency of at-risk vessels.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EchoMark | EchoMark is implanted during surgery to mark the at-risk blood vessels to enable EchoSure ultrasound-based monitoring |
| DEVICE | EchoSure | EchoSure ultrasound scans are performed to monitor the free flap |
Timeline
- Start date
- 2019-09-19
- Primary completion
- 2022-05-05
- Completion
- 2022-05-05
- First posted
- 2019-04-16
- Last updated
- 2024-11-26
- Results posted
- 2024-11-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03915717. Inclusion in this directory is not an endorsement.