NCT06902129

Validation of Safety and Performance of Three EDDIS Breath-Activated Portable Inhalation Systems

Engineering Evaluation of Aerosol Flow, Inhalation Pattern Control, and Digital Accuracy in Three Breath-Activated EDDIS Systems (VMT, Atomizer, Ultrasonic) Using Inert NaCl-Based Formulation With Chitosan Nanoparticles

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Petrov, Andrey · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a crossover study to evaluate real-time performance, airflow control, user-device interaction, and safety systems of three portable inhalation systems from the EDDIS platform. The formulation is non-pharmacological and inert. Each volunteer will use all three devices in random order. Primary endpoints focus on gas dynamics, inhalation recording accuracy, device integrity, and user tolerability.

Detailed description

This is a device-only evaluation of three portable inhalation delivery systems from the EDDIS platform (VMT, Atomizer, Ultrasonic). The study focuses on technical performance, gas dynamics, safety system integrity, and user-device interaction under controlled conditions in healthy adult volunteers. Each device is breath-actuated, disposable, and digitally integrated with a smartphone application. The inhaled formulation consists of sterile 0.9% sodium chloride containing suspended chitosan nanoparticles (\<200 nm), designed to simulate complex aerosol behavior without delivering any active pharmaceutical ingredients. The study employs a crossover design, allowing each subject to evaluate all three devices in a randomized sequence. Performance characteristics such as airflow resistance, aerosol output, inspiratory detection sensitivity, power consumption, and digital logging accuracy will be assessed. Special emphasis is placed on safety-related engineering features, including detection of abnormal inhalation patterns (e.g., cough-like events), child-lock functionality, and plume behavior under variable user conditions. This study does not involve any drug or therapeutic intervention, is not classified as a clinical investigation under EU MDR or Swissmedic regulations, and does not require ethics committee oversight. The primary objective is to validate the EDDIS platform as a modular, scalable, and precisely controlled aerosol delivery system suitable for further development in both clinical and non-clinical applications.

Conditions

• Healthy Volunteers
• Drug Delivery Systems
• Inhalation of Liquid Air
• Administration Site Injury

Interventions

Type	Name	Description
DEVICE	EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic)	A set of three single-use, disposable, closely matched and uniform in size, breath-actuated, digitally monitored portable inhalation devices designed for precision aerosol delivery. Devices include a vibrating mesh (VMT), an atomizer-based unit (ATM), and an ultrasonic micro-vibration unit (ULT). Each system records inhalation parameters and connects via Bluetooth to a mobile application for real-time feedback and logging. Used to assess technical performance, gas dynamics, and digital control functions using a non-active NaCl-based aerosol with chitosan nanoparticles.

Timeline

• Start date: 2025-11-09
• Primary completion: 2026-03-10
• Completion: 2026-04-12
• First posted: 2025-03-30
• Last updated: 2025-11-18

Locations

1 site across 1 country: Switzerland