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NOT YET RECRUITING
NCT06902129
NA

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

Sponsor: Petrov, Andrey

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

21 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-11-09

Completion Date

2026-04-12

Last Updated

2025-11-18

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Central Contact

Lausanne, Switzerland