Back to resultsClinical Evaluation of the CM-1500 in Postoperative Surgery Patients
Primary Purpose
Blood Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CM-1500
Sponsored by
About this trial
This is an interventional diagnostic trial for Blood Loss
Eligibility Criteria
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
Sites / Locations
- Wake Forest University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Blood Volume Monitoring
Arm Description
Outcomes
Primary Outcome Measures
Relative Index Change
The primary objective is to evaluate the the changes in the Relative Index in post abdominal or pelvic surgery patients
Secondary Outcome Measures
Full Information
NCT ID
NCT04706221
First Posted
January 8, 2021
Last Updated
December 3, 2021
Sponsor
Zynex Monitoring Solutions
Collaborators
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04706221
Brief Title
Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients
Official Title
Clinical Evaluation of the CM-1500 in Postoperative Abdominal and Pelvic Surgery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
November 29, 2021 (Actual)
Study Completion Date
November 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zynex Monitoring Solutions
Collaborators
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study is a prospective, single-arm, non-randomized, non-controlled, single-center study enrolling adult subjects.
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blood Volume Monitoring
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CM-1500
Intervention Description
Blood volume monitor CM-1500
Primary Outcome Measure Information:
Title
Relative Index Change
Description
The primary objective is to evaluate the the changes in the Relative Index in post abdominal or pelvic surgery patients
Time Frame
Acute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients
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