Status:

COMPLETED

Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients

Lead Sponsor:

Zynex Monitoring Solutions

Collaborating Sponsors:

Wake Forest University Health Sciences

Conditions:

Blood Loss

Eligibility:

All Genders

18-100 years

Phase:

NA

Brief 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 detec...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 15 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 29 2021

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT04706221

Start Date

January 15 2021

End Date

November 29 2021

Last Update

March 27 2024

Active Locations (1)

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1

Wake Forest University

Winston-Salem, North Carolina, United States, 27109