STIMIT Activator 1 IDE Pivotal Study

Diaphragm Issues Clinical Trial

Official title:

STIMIT Activator 1 Pivotal Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05883163
• Other study ID #: D26606
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Stimit AG
• Contact: Mary B Tate
• Phone: 7347092080
• Email: marybeth.kepler[@]globalmedicaldeviceconsultants.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 48 hours and are predicted to require additional minimum 48 hours of mechanical ventilation or longer (adding up to MV time approximately 96 hours or longer).

Description:

The objective of this clinical investigation is to evaluate the safety and efficacy of the STIMIT Activator 1 device in subjects on mechanical ventilation who are on invasive mechanical ventilation (MV) and thus are at risk of diaphragmatic dysfunction/atrophy. 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 48 hours and are predicted to require additional minimum 48 hours of mechanical ventilation or longer (adding up to MV time approximately 96 hours or longer). This pivotal study is expected to include 40 subjects enrolled and device interventions in up to 6 centers focusing on North American sites (main focus USA, > 50% of study enrollment from US site). An interim analysis will be conducted after 30 patients have been treated to reconfirm sample size (adaptive design). This clinical study is anticipated to commence in the US upon approval by FDA and local IRB/EC site approval, and Canada upon approval of competent authorities and Ethics Committees. Enrollment and 10-day follow-up duration for primary endpoint of the study is expected to last 6 months. Subjects will be followed for 10 days or until they are successfully extubated (weaned) from mechanical ventilation, expire, or withdraw consent.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Informed consent in writing from patient or the legally authorized representative

2. Are 21 years or older, and,

3. Have been on invasive mechanical ventilation = 48hours and are predicted to remain on MV for an additional 48 hours or longer*

• Prediction at time of enrollment

Exclusion Criteria:

1. Patients that are planned to be treated with continuous infusion of neuromuscular blocking agents beyond the 48h enrollment period.

2. Medical condition known to affect the phrenic nerve or respiratory muscles (non-exclusive list of medical conditions that could affect the phrenic nerve)

3. Any patients with ICP probe

4. Pre-existing severe chronic pulmonary disease (COPD GOLD stage IV, severe pulmonary fibrosis)

5. 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

6. 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

7. BMI >40

8. Cardiogenic or septic shock with ongoing severe hemodynamic instability as defined according to American College of Chest Physicians (Bone et al. 1992) (Singer et al. 2016)) that cannot be stabilized within the 48 hours enrollment period

9. Physician thinks that the patient will not tolerate initial installation of the STIMIT respiratory sensor.

10. Anticipating withdrawal of life support and/or shift to palliation as the goal of care (refer to Annex 2)

11. Known to be pregnant

12. Participating in another clinical trial studying an experimental Intervention that could affect the study primary outcome.

13. Patients whose ultrasonographic assessment of right-sided diaphragmatic thickness would be difficult (e.g. local subcutaneous emphysema surrounding the zone of apposition, large dressings in the zone of apposition that cannot be removed).

14. Patients with any neck incision, bruising, or other skin condition that places the subject at risk for burns.

Related Conditions & MeSH terms

• Diaphragm Issues

Intervention

Device:
• Stimit Activator 1
The Stimit Activator 1 System will be used to stimulate the phrenic nerve resulting in diaphragm activation.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	YALE New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Stimit AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preservation of Diaphragm Thickness	The intra-individual change in diaphragm thickness will be measured daily via ultrasound.	Up to 10 days or extubation, whichever occurs first.
Primary	the rate of device or procedure related serious adverse events	Events will be collected for intervention group during the course of treatment.	Up to 10 days or extubation, whichever occurs first.
Secondary	Preservation of Diaphragm Thickness	The intra-individual change in diaphragm thickness will be measured daily via ultrasound.	Up to Day 4.
Secondary	Time to Rapid Shallow Breathing Index (RSBI) < 105	Time from intubation to RSBI<105 breaths/min/L in days will be compared between Intervention and control groups.	UP to Day 10
Secondary	Maximum Inspiratory Pressure (MIP) at extubation	MIP at extubation will be compared between the intervention and control groups.	UP to Day 10