NCT05012462

Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Zynex Monitoring Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 200 healthy adult subjects consented to undergo an apheresis donation procedure. Subjects will be connected to the Zynex Cardiac Monitor, Model 1500 (CM-1500) to characterize changes in the relative index during an apheresis donation procedure.

Conditions

• Fluid Loss

Interventions

Type	Name	Description
DEVICE	CM-1500	The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value.
DEVICE	CM-1600	The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors Bioelectrical Impedance, Photoplethysmography (PPG) Amplitude, ECG Amplitude and Skin Temperature. A combination of these parameters is represented by a single number known as the Relative Index value.

Timeline

• Start date: 2021-09-20
• Primary completion: 2022-12-20
• Completion: 2022-12-20
• First posted: 2021-08-19
• Last updated: 2024-12-06
• Results posted: 2024-12-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study