At a glance
ClinicalIndex Comparison RecordN/ACompleted· 351 enrolled
Drug / intervention
CM-1600device
Likely dose
CM-1600 device application during blood donationAI-extracted
Key inclusion· 4
- ✓Age 18 years or older
- ✓Able to provide written informed consent
- ✓Willing and able to comply with study procedures
- ✓Eligible to undergo a single unit whole blood donation
Key exclusion· 5
- ✕Pregnant or breastfeeding females
- ✕History of upper extremity amputation
- ✕Diagnosed with dextrocardia
- ✕Has a pacemaker
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600
In Brief
A clinical study evaluating CM-1600 for Fluid Loss. Completed, enrolled 351 participants across 4 sites.
Detailed Summary
The study is a prospective, non-randomized, non-blinded, non-significant risk, multi-center study enrolling up to 500 healthy adult subjects consented to undergo a whole blood donation procedure. The study will involve enrolling subjects that will undergo blood donation wearing the study device (CM-1600 Device) and capture study-required physiological parameters pre-, during, and post-donation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFluid Loss
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2023202420252026
First PostedJul 2022
Enrollment StartSep 2022
Primary CompletionApr 2023
Study CompletionMay 2023
TodayJul 2026
First PostedJul 18, 2022
Enrollment StartSep 14, 2022
Primary CompletionApr 27, 2023
Study CompletionMay 26, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.0 years ago
Interventions
CM-1600device
Subjects undergoing blood donation will be connected to the CM-1600 device.