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NCT05463198 · ClinicalTrials.gov registry record · NA
Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600
A NA study, sponsored by Zynex Monitoring Solutions.
- Completed
- Registry status
- NA
- Development phase
- 351
- Enrollment target
NCT05463198: Completed NA study, sponsored by Zynex Monitoring Solutions.
NCT05463198 is a NA study that has completed, run by Zynex Monitoring Solutions. The registered enrollment target is 351 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05463198, a NA study, has completed, sponsored by Zynex Monitoring Solutions.
- COMPLETED
- Registry status
- NA
- Development phase
- 351 participants
- Enrollment target
Study 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.
Primary Outcome
The objective of this study is to determine if manual blood loss of up to 500mL of blood can be identified using the non-invasive Zynex CM-1600. This will be measured by determining the percent change in Relative Index (RI) before and after the Blood Draw. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume
Interventions
- DEVICE CM-1600
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 351 participants |
| Start Date | 2022-09-14 |
| Est. Completion | 2023-05-26 |
| Phase | NA |
What the finished NCT05463198 record still lists
NCT05463198 is an interventional study that assigns participants to a tested intervention. The registered 351 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which CM-1600 is the first listed.
NCT05463198 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05463198 about?
NCT05463198 is a clinical study titled "Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600". 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-...
What is the current status of trial NCT05463198?
This trial is currently completed. It is a NA study. The enrollment target is 351 participants. The study started on 2022-09-14. Estimated completion is 2023-05-26.
What interventions are being tested in trial NCT05463198?
The interventions under investigation include: CM-1600 (DEVICE).
Who is sponsoring clinical trial NCT05463198?
This trial is sponsored by Zynex Monitoring Solutions, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05463198's enrollment target sits among peer trials
351 292nd of 2000 higher than 1,709 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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