N/A
N=200
Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients
Blood Loss
Bottom Line
View on ClinicalTrials.gov: NCT04706221 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Relative Index Change During PACU Stay — -2.01; -1.32 Relative Index (RI)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CM-1500 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zynex Monitoring Solutions
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Index Change During PACU Stay |
-2.01; -1.32 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04706221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.