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Device

Stimulation Group for Diaphragm Dysfunction

Q: Is this clinical trial currently open for enrollment?

<p>As indicated on clinicaltrials.gov, this investigation is currently seeking suitable candidates. The trial was initially posted on 11th of July 2023 and last revised on the 4th of November 2024.</p>

Q: What is the current number of individuals undergoing treatment within this medical study?

<p>This clinical trial necessitates the enrollment of 40 eligible candidates who meet the defined inclusion criteria. Patients have the opportunity to join this study at multiple locations, such as YALE New Haven Hospital in New Haven, <a href="https://www.withpower.com/clinical-trials/connecticut">Connecticut</a> and Beth Israel Deaconess Medical Center in Boston, <a href="https://www.withpower.com/clinical-trials/massachusetts">Massachusetts</a>.</p>

N/A

Recruiting

Led By Laurent Brochard, MD

Research Sponsored by Stimit AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are 21 years or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 10

Awards & highlights

Study Summary

This trial will test a new device called the STIMIT Activator 1 System on patients who have been on a ventilator for at least 48 hours and are expected to need it for another

Who is the study for?

This trial is for adults over 21 who have been on a mechanical ventilator for up to 48 hours and are expected to need it for at least another 48 hours. They must be able to give written consent themselves or through a legal representative.Check my eligibility

What is being tested?

The STIMIT Activator 1 System is being tested in this study. It's designed to help patients with diaphragm dysfunction who require prolonged mechanical ventilation. The study compares the safety and performance of this system against standard care in several medical centers.See study design

What are the potential side effects?

Specific side effects of the STIMIT Activator 1 System aren't detailed, but may include discomfort or complications related to device use, as well as potential risks associated with extended mechanical ventilation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 21 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

the rate of device or procedure related serious adverse events

Secondary outcome measures

Maximum Inspiratory Pressure (MIP) at extubation

Preservation of Diaphragm Thickness

Time to Rapid Shallow Breathing Index (RSBI) < 105

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Stimulation GroupExperimental Treatment1 Intervention

The intervention group will receive non-invasive stimulation of the phrenic nerve for activation of the diaphragm.

Group II: Control GroupActive Control1 Intervention

The control group will not received intervention and will be treated with standard of care.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stimit AGLead Sponsor

4 Previous Clinical Trials

30 Total Patients Enrolled

Laurent Brochard, MDPrincipal InvestigatorSt Michael's Hospital Unity Health Toronto

11 Previous Clinical Trials

3,604 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial currently open for enrollment?

"As indicated on clinicaltrials.gov, this investigation is currently seeking suitable candidates. The trial was initially posted on 11th of July 2023 and last revised on the 4th of November 2024."

Answered by AI

What is the current number of individuals undergoing treatment within this medical study?

"This clinical trial necessitates the enrollment of 40 eligible candidates who meet the defined inclusion criteria. Patients have the opportunity to join this study at multiple locations, such as YALE New Haven Hospital in New Haven, Connecticut and Beth Israel Deaconess Medical Center in Boston, Massachusetts."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

STIMIT Activator 1 IDE Pivotal Study

2023. "STIMIT Activator 1 IDE Pivotal Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05883163.