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NCT05980013 · ClinicalTrials.gov registry record · NA

Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the CM-1500

A NA study, sponsored by Zynex Monitoring Solutions.

Completed
Registry status
NA
Development phase
120
Enrollment target

NCT05980013: Completed NA study, sponsored by Zynex Monitoring Solutions.

NCT05980013 is a NA study that has completed, run by Zynex Monitoring Solutions. The registered enrollment target is 120 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05980013, a NA study, has completed, sponsored by Zynex Monitoring Solutions.

COMPLETED
Registry status
NA
Development phase
120 participants
Enrollment target

Study 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.

Primary Outcome

The objective of this study is to determine if manual blood loss of up to 500mL of blood affects heart rate. This will be measured by determining the percent change in HR before and after the Blood Draw. The percent change will be calculated separately for each Arm (reclined, supine). Based on previous studies, a positive outcome would be indicated by an increase in HR (i.e., positive percent change).

Interventions

  • DEVICE Whole blood donation supine
  • DEVICE Whole blood donation reclined

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2023-08-28
Est. Completion 2024-04-10
Phase NA
Zynex Monitoring Solutions

9 total trials

What the finished NCT05980013 record still lists

NCT05980013 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 2 interventions - of which Whole blood donation supine is the first listed.

NCT05980013 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05980013 about?

NCT05980013 is a clinical study titled "Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the CM-1500". 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 bl...

What is the current status of trial NCT05980013?

This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2023-08-28. Estimated completion is 2024-04-10.

What interventions are being tested in trial NCT05980013?

The interventions under investigation include: Whole blood donation supine (DEVICE), Whole blood donation reclined (DEVICE).

Who is sponsoring clinical trial NCT05980013?

This trial is sponsored by Zynex Monitoring Solutions, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05980013's enrollment target sits among peer trials

120 762nd of 2000 higher than 1,198 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05980013, the US trial registry maintained by the National Library of Medicine. NCT05980013 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.