NCT04706221

Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients

Clinical Evaluation of the CM-1500 in Postoperative Abdominal and Pelvic Surgery Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Zynex Monitoring Solutions · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate the the changes in the Relative Index in post abdominal or pelvic surgery patients on the Cardiac Monitor Model CM-1500.

Detailed description

Postoperative hemorrhage incidence can vary depending on the type of surgery, but it can lead to severe clinical complications ranging from mild anemia to fatal hemorrhagic shock. Monitoring and detecting these fluid changes postoperatively can be complicated, and standard operating procedures vary. The Cardiac Monitor, Model 1500 (CM-1500), uses a personalized approach by non-invasively and simultaneously monitoring five (5) physiological parameters.

Conditions

• Blood Loss

Interventions

Type	Name	Description
DEVICE	CM-1500	Blood volume monitor CM-1500

Timeline

• Start date: 2021-01-15
• Primary completion: 2021-11-29
• Completion: 2021-11-29
• First posted: 2021-01-12
• Last updated: 2024-03-27
• Results posted: 2024-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study