RECRUITING

STIMIT Activator 1 IDE Study

Conditions

Diaphragm Issues Non-Invasive Phrenic Nerve Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study is a prospective, multi-center, randomized, controlled study using adaptive design to assess the evidence of safety and performance of the STIMIT Activator 1 System in the treatment of patients who have been mechanically ventilated for up to 7 days and are predicted to require additional minimum 48 hours of mechanical ventilation or longer.

Official Title

STIMIT Activator 1 Pivotal Study

Quick Facts

Study Start:2024-01-24

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05883163

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Are 21 years or older, and, 2. Have recently been placed on invasive MV (enroll and randomized as soon as possible after intubation), and have received no more than 7 days of MV 3. Are predicted to remain on mechanical ventilation for an additional 48 hours or longer post randomization	1. Patients that are actively treated with continuous infusion of neuromuscular blocking agents beyond the enrollment period. 2. Medical condition known to affect the phrenic nerve or respiratory muscles (examples of possible medical conditions that could affect the phrenic nerve provided in Annex 1 below). 3. Any patients with ICP probe. 4. Patients with metallic device implants or body penetrating metallic devices in the upper body area within 30cm (12inches) from the coils; known anatomy or devices in the neck area (e.g., ECMO cannulas in the neck area, collars or cranial appliances) that would interfere with headset placement or stimulation. 5. Any non-removable electrical / electronic device (device internal or external) that may be prone to interaction with, or interference from the STIMIT Activator, such as pacemakers, implantable defibrillators, implanted medication pumps, bio-stimulators, deep brain stimulators, implanted nerve stimulator, deep brain stimulators or cochlear device implants. 6. BMI \>40. 7. Cardiogenic or septic shock with ongoing severe hemodynamic instability that cannot be stabilized within the enrollment period. 8. Physician thinks that the patient will not tolerate initial installation of the STIMIT respiratory sensor. 9. Anticipating withdrawal of life support and/or shift to palliation as the goal of care. 10. Known to be pregnant. 11. Participating in another clinical trial studying an experimental Intervention that could affect the study primary outcome. 12. Patients whose ultrasonographic assessment of right-sided diaphragmatic thickness would be too difficult (e.g. local subcutaneous emphysema surrounding the zone of apposition, large dressings in the zone of apposition that cannot be removed). 13. Patients with neck condition that would not allow placing the coils on the neck (e.g. open wounds that cannot be covered, skin at risk for burns). 14. Patients with significant spontaneous efforts (P0.1 \< - 2) that would not be at risk for diaphragmatic atrophy/ dysfunction.

Inclusion Criteria

Exclusion Criteria

1. Are 21 years or older, and,
2. Have recently been placed on invasive MV (enroll and randomized as soon as possible after intubation), and have received no more than 7 days of MV
3. Are predicted to remain on mechanical ventilation for an additional 48 hours or longer post randomization

1. Patients that are actively treated with continuous infusion of neuromuscular blocking agents beyond the enrollment period.
2. Medical condition known to affect the phrenic nerve or respiratory muscles (examples of possible medical conditions that could affect the phrenic nerve provided in Annex 1 below).
3. Any patients with ICP probe.
4. Patients with metallic device implants or body penetrating metallic devices in the upper body area within 30cm (12inches) from the coils; known anatomy or devices in the neck area (e.g., ECMO cannulas in the neck area, collars or cranial appliances) that would interfere with headset placement or stimulation.
5. Any non-removable electrical / electronic device (device internal or external) that may be prone to interaction with, or interference from the STIMIT Activator, such as pacemakers, implantable defibrillators, implanted medication pumps, bio-stimulators, deep brain stimulators, implanted nerve stimulator, deep brain stimulators or cochlear device implants.
6. BMI \>40.
7. Cardiogenic or septic shock with ongoing severe hemodynamic instability that cannot be stabilized within the enrollment period.
8. Physician thinks that the patient will not tolerate initial installation of the STIMIT respiratory sensor.
9. Anticipating withdrawal of life support and/or shift to palliation as the goal of care.
10. Known to be pregnant.
11. Participating in another clinical trial studying an experimental Intervention that could affect the study primary outcome.
12. Patients whose ultrasonographic assessment of right-sided diaphragmatic thickness would be too difficult (e.g. local subcutaneous emphysema surrounding the zone of apposition, large dressings in the zone of apposition that cannot be removed).
13. Patients with neck condition that would not allow placing the coils on the neck (e.g. open wounds that cannot be covered, skin at risk for burns).
14. Patients with significant spontaneous efforts (P0.1 \< - 2) that would not be at risk for diaphragmatic atrophy/ dysfunction.

Contacts and Locations

Study Contact

Tsiry Rabemahefa

CONTACT

218-329-7356

tsiry.rabemahefa@stimit.com

Principal Investigator

Laurent Brochard, MD

PRINCIPAL_INVESTIGATOR

St Michael's Hospital Unity Health Toronto

Study Locations (Sites)

Yale New Haven Hospital

New Haven, Connecticut, 06510

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

University of Virginia Medical Center

Charlottesville, Virginia, 22908

United States

Collaborators and Investigators

Sponsor: Stimit AG

Laurent Brochard, MD, PRINCIPAL_INVESTIGATOR, St Michael's Hospital Unity Health Toronto

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-24

Study Completion Date2026-07

Study Record Updates

Study Start Date2024-01-24

Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

Non-Invasive Phrenic Nerve Stimulation

Additional Relevant MeSH Terms

Diaphragm Issues