Trials / Completed
CompletedNCT03621202
Safety and Accuracy of the Saranas EBBMS for the Detection of Endovascular Procedure Related Bleeding Events
A Clinical Study to Evaluate the Safety and Accuracy of the Saranas Early Bird Bleed Monitoring System for the Detection of Endovascular Procedure Related Bleeding Events
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Saranas, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and accuracy of the Saranas EBBMS for the detection of access site related internal bleeding events during large-bore endovascular procedures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Saranas Early Bird Bleed Monitoring System (EBBMS) | Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS. |
Timeline
- Start date
- 2018-08-13
- Primary completion
- 2019-06-30
- Completion
- 2019-06-30
- First posted
- 2018-08-08
- Last updated
- 2020-12-28
- Results posted
- 2020-12-28
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03621202. Inclusion in this directory is not an endorsement.