Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients

NCT04706221 | Completed Results FDA Device

• 1 other identifier: ZMS-1500-2001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Loss

Outcome Measures

Primary Outcomes (1)

• Relative Index Change During PACU Stay

  The primary objective is to evaluate changes in the Relative Index (RI) in post-abdominal or pelvic surgery patients (Laparoscopic or Open). The CM-1500 monitors parameters which are indicative of relative changes in fluid volume in adult patients. The Relative Index is an investigational value which utilizes proprietary algorithms to combine the relative changes of each measured parameter into a single value. The Relative Index is graded on a scale where 100 indicates a patient's baseline, and changes up or down from the baseline could be used as potential indicators of fluid gain or loss relative to the baseline, based on the changes of the individually monitored parameters. Per the device's FDA 510(k) clearance, the RI is computed as the weighted summation of the percent change values (signifying the deviation of each parameter from it's baseline value) for its parameters. Change in RI is calculated by subtracting the initial RI value from the final RI value during monitoring.

  Length of PACU Stay (Range: 46 to 353 minutes)

Study Arms (1)

Blood Volume Monitoring

EXPERIMENTAL

Device: CM-1500

Interventions

CM-1500 DEVICE

Blood volume monitor CM-1500

Blood Volume Monitoring

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zynex Monitoring Solutions: lead
• Wake Forest University Health Sciences: collaborator

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Donald Gregg
• Organization: Zynex Monitoring Solutions

dgregg@zynex.com

(800) 495-6670

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a prospective, single-arm, non-randomized, non-controlled, single-center study enrolling adult subjects.

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 12, 2021
• Study Start: January 15, 2021
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2021
• Last Updated: March 27, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-02

Locations

US (1)