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NCT06023511 · ClinicalTrials.gov registry record · NA

Safety and Efficacy of the MyokinE100 (CL-EMS Alpha) Device in Inducing Visible Muscle Contraction in Healthy Volunteers

A NA study of ICU Acquired Weakness, sponsored by Health Discovery Labs.

Completed
Registry status
NA
Development phase
8
Enrollment target
1
Study location

NCT06023511: Completed NA study of ICU Acquired Weakness, sponsored by Health Discovery Labs.

NCT06023511 is a NA study of ICU Acquired Weakness that has completed, run by Health Discovery Labs. The registered enrollment target is 8 participants, below the 2,113-participant average among 4 other ICU Acquired Weakness trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06023511, a NA study of ICU Acquired Weakness, has completed, sponsored by Health Discovery Labs.

COMPLETED
Registry status
NA
Development phase
8 participants
Enrollment target
1
Study location

Study Summary

Every patient admitted to the Intensive Care Unit (ICU) is at risk of developing "Intensive Care Unit Acquired Weakness" (ICUAW). ICUAW is associated with increased rate of mortality, prolonged duration of mechanical ventilation, ICU and hospital stay, rehabilitation time, and reduced quality of life. Currently, there is no effective treatment for ICUAW. Health Discovery Labs is conducting a research study to evaluate the safety of using an innovative experimental medical device in ICU settings that could mitigate ICUAW. This study is meant to demonstrate whether this new device interferes with standard ICU monitors.

Primary Outcome

During electrical muscle stimulation using the MyokinE100 (CL-EMS alpha) device at the level of the quadriceps muscle, volunteers will be connected to cardiac monitoring device. ECG will be monitored for the detection of electric interference or the detection of noise suggestive of dysrhythmias. Success will be based on the following criteria: (1) intervention does not induce noise of more than 0.1mV in amplitude; and (2) does not introduce signal suggestive of cardiac dysrhythmias (VT/VF/AF/PV

Conditions Studied

ICU Acquired Weakness

Interventions

  • DEVICE Electrical muscle stimulation

Study Locations (1)

Texas

  • Ascension Texas Clinical Education Center (CEC) - Austin

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2023-08-22
Est. Completion 2023-08-23
Phase NA
Health Discovery Labs

2 total trials

What the finished NCT06023511 record still lists

NCT06023511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 2,113-participant average among 4 other ICU Acquired Weakness trials with a reported enrollment target (100% lower).

The record links to 1 condition, with ICU Acquired Weakness appearing as the primary indexed condition, and to 1 intervention - of which Electrical muscle stimulation is the first listed.

NCT06023511 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT06023511 about?

NCT06023511 is a clinical study titled "Safety and Efficacy of the MyokinE100 (CL-EMS Alpha) Device in Inducing Visible Muscle Contraction in Healthy Volunteers". Every patient admitted to the Intensive Care Unit (ICU) is at risk of developing "Intensive Care Unit Acquired Weakness" (ICUAW). ICUAW is associated with increased rate of mortality, prolonged duration of mechanical ventilation, ICU and hospital stay, rehabilitation time, and reduced quality of lif...

What is the current status of trial NCT06023511?

This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2023-08-22. Estimated completion is 2023-08-23.

What conditions does trial NCT06023511 study?

This clinical trial studies the following conditions: ICU Acquired Weakness.

What interventions are being tested in trial NCT06023511?

The interventions under investigation include: Electrical muscle stimulation (DEVICE).

Who is sponsoring clinical trial NCT06023511?

This trial is sponsored by Health Discovery Labs, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06023511 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT06023511, the US trial registry maintained by the National Library of Medicine. NCT06023511 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.