NCT05125848

Clinical Evaluation of the CM-1500 During Hemodialysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Zynex Monitoring Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 20 subjects consented to undergo a hemodialysis session as a part of their standard prescribed treatment plan. Subjects will consent to undergo non-invasive monitoring with the CM-1500 during three (3) separate sequential hemodialysis sessions.

Conditions

• Fluid Loss
• Dialysis

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. This value is indicative of relative changes in fluid volume.

Timeline

• Start date: 2021-11-29
• Primary completion: 2022-03-04
• Completion: 2022-03-04
• First posted: 2021-11-18
• Last updated: 2024-05-01
• Results posted: 2024-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study