N/A
Completed N=120
Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the CM-1500
Fluid Loss · Blood Loss
Source: ClinicalTrials.gov NCT05980013 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Impact of Subject Positioning on Percent Change of Heart Rate (HR) After Minor Blood Loss (e.g., 500mL) — 10.7; 14.7 percent change
Summary
The study is a prospective, non-randomized, non-blinded, non-significant risk study enrolling up to 60 healthy adult subjects consented to undergo a 1-unit whole blood draw procedure. Subjects will wear the study device (CM-1500) while positioned in either a supine or reclined position during the blood draw and study-required physiological parameters will be captured pre-, during, and post-donation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Impact of Subject Positioning on Percent Change of Heart Rate (HR) After Minor Blood Loss (e.g., 500mL) |
10.7; 14.7 | — |
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 and eligible to undergo a single unit whole blood donation
Exclusion Criteria
- Females who are pregnant or breastfeeding
- Undergone an amputation of any upper extremity
- Diagnosed with dextrocardia
- Subjects who have a pacemaker
- Subjects with body hair density which prevents adequate application of device electrodes
Data sourced from ClinicalTrials.gov (NCT05980013). 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.