Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood Draw

Zynex Monitoring Solutions

Status and phase: Completed; Phase 1

Conditions: Blood Loss

Treatments: Device: CM1500

Study type: Interventional

Funder types: Industry

Identifiers

NCT01834612

Zynex 750

Details and patient eligibility

About

To determine if a manual blood loss can be detected using the non-invasive blood monitor.

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteer
• between 18 to 50 years of age
• weight between 157 to 220 lbs

Exclusion criteria

• unstable or untreated cardia disease
• alcohol consumption in 24 hours prior to screening
• tobacco use in 4 hours prior to screening
• pregnancy
• infection
• Hemoglobin < 12.5 g/dL at time of procedure

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Blood draw

Active Comparator group

Description:

CM1500 with blood draw

Treatment:

Device: CM1500

No blood draw

Sham Comparator group

Description:

CM 1500 with no blood draw

Treatment:

Device: CM1500