N/A
Completed N=77
Clinical Evaluation of the CM-1500 During Apheresis Blood Donation
Source: ClinicalTrials.gov NCT05012462 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Characterize Changes in the Relative Index During an Apheresis Procedure — 94.9; 99.3 Relative Index
Summary
The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 200 healthy adult subjects consented to undergo an apheresis donation procedure. Subjects will be connected to the Zynex Cardiac Monitor, Model 1500 (CM-1500) to characterize changes in the relative index during an apheresis donation procedure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Characterize Changes in the Relative Index During an Apheresis Procedure |
94.9; 99.3 | — |
Eligibility Criteria
Inclusion Criteria
- Ability to provide written informed consent
- Ability and willingness to comply with the study procedures and duration requirements
- 18 years of age or older
- Consented to undergo an apheresis procedure with an automated blood component device
Exclusion Criteria
- Females who are pregnant or breastfeeding
- Undergone an amputation of the left upper extremity
- Diagnosed with dextrocardia
- Subjects who have a pacemaker
Data sourced from ClinicalTrials.gov (NCT05012462). 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. Informational only — not medical advice.