Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients

Zynex Monitoring Solutions

Status: Completed

Conditions: Blood Loss

Treatments: Device: CM-1500

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04706221

ZMS-1500-2001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to provide written informed consent
• Ability and willingness to comply with study procedures and duration requirements
• 18 years of age or older
• Undergoing an abdominal or pelvic surgery within the next 10 days

Exclusion criteria

• Females who are pregnant or breastfeeding
• Participation in other clinical studies involving experimental drugs or devices
• Undergone an amputation of the left upper extremity
• Diagnosed with Dextrocardia
• Subjects who have a Pacemaker

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Blood Volume Monitoring

Experimental group

Treatment:

Device: CM-1500