Trials / Completed
CompletedNCT05463198
Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 351 (actual)
- Sponsor
- Zynex Monitoring Solutions · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The study is a prospective, non-randomized, non-blinded, non-significant risk, multi-center study enrolling up to 500 healthy adult subjects consented to undergo a whole blood donation procedure. The study will involve enrolling subjects that will undergo blood donation wearing the study device (CM-1600 Device) and capture study-required physiological parameters pre-, during, and post-donation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CM-1600 | Subjects undergoing blood donation will be connected to the CM-1600 device. |
Timeline
- Start date
- 2022-09-14
- Primary completion
- 2023-04-27
- Completion
- 2023-05-26
- First posted
- 2022-07-18
- Last updated
- 2024-08-13
- Results posted
- 2024-08-13
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05463198. Inclusion in this directory is not an endorsement.