NCT05980013

Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the CM-1500

Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the Zynex Cardiac Monitor, Model 1500 (CM-1500)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (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 study enrolling up to 60 healthy adult subjects consented to undergo a 1-unit whole blood draw procedure. Subjects will wear the study device (CM-1500) while positioned in either a supine or reclined position during the blood draw and study-required physiological parameters will be captured pre-, during, and post-donation.

Conditions

• Fluid Loss
• Blood Loss

Interventions

Type	Name	Description
DEVICE	Whole blood donation supine	Subjects will undergo a 1-unit whole blood donation in a supine position
DEVICE	Whole blood donation reclined	Subjects will undergo a 1-unit whole blood donation in a reclined position

Timeline

• Start date: 2023-08-28
• Primary completion: 2024-04-10
• Completion: 2024-04-10
• First posted: 2023-08-07
• Last updated: 2025-05-02
• Results posted: 2025-05-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study