Not yet taking people in United StatesNo phase

Simeox 200 airway clearance device for bronchiectasis with excess mucus

Tests the Simeox 200 device for clearing mucus in adults with bronchiectasis.

Key facts

Who runs it: Inogen Inc.
Where: Charleston, United StatesSee the site
Trial code: NCT07443124
Registry title: Simeox 200 US Study
Status: Not yet recruiting
People taking part: 35 people, planned
Started: Feb 2026
Planned end: Jun 2026
Type of study: Interventional
Treatments tested: Intermittent intrapulmonary deflation
Record updated: 2 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with bronchiectasis who cough up mucus every day. They will use the Simeox 200 airway clearance device for 2 weeks.

Age: 18 to 85 years
Sex: All sexes
Disease stage: Bronchiectasis confirmed by a chest CT scan in the prior 36 months. Ongoing cough with mucus, more than 1 tsp or 5 ml a day. Stable, with no lung flare-up in the past 4 weeks.
Earlier treatment: Daily airway clearance therapy must be prescribed.

Main reasons for not taking part

Cannot cough strongly on your own, or breathing support through a tube or mask (night-time CPAP is allowed)
Severe restrictive lung disease (FVC <60% of predicted) or nerve-muscle disease with weak breathing muscles
Unstable heart disease or unstable blood circulation
Recent surgery: upper airway in prior 3 months, heart, chest or esophagus in prior 6 months; collapsed lung in prior 6 months
Pregnant or breastfeeding

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

Diagnosis of bronchiectasis confirmed by computed chest tomography (CT chest) performed within the prior 36 months
Persistent productive cough for which daily airway clearance therapy is prescribed
Daily sputum production estimated at > 1 tsp or 5 ml
Clinically stable on medical regimen with no pulmonary exacerbation in the past 4 weeks prior to study enrolment
Subject able to sign informed consent

Who cannot take part

Upper airway surgery in the prior 3 months
Cardiothoracic surgery, including esophageal surgery, in the prior 6 months
History of pneumothorax within the prior 6 months
History of haemoptysis treated with embolization within the prior 12 months
Neuromuscular disease with muscle respiratory weakness
Severe restrictive lung disease defined as Forced Vital Capacity (FVC) <60% of predicted
Unstable cardiac disease (e.g. major cardiac arrhythmia, unstable heart failure, heart attack, unstable angina)
Uncontrolled gastroesophageal reflux disease (GERD) as determined by the clinician
Inability to use airway clearance therapy as directed
Inability to cough forcefully and independently, as determined by the clinician
Ventilatory assistance with endotracheal tube, tracheostomy tube, or mask (not including nocturnal CPAP)
Hemodynamic instability, as determined by the clinician
Airway at risk for aspiration, as determined by the clinician
Anticipated hospitalization within the next 2 weeks
Unable or unwilling to complete study visits or provide follow-up data as required per the study protocol
Pregnant or lactating female

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 85 years old?

Where in United States

Medical University of South CarolinaCharleston, United StatesContact: Patrick A Flume, MDNot yet recruiting

About the trial

What the trial wants to find out

The purpose of this single arm post-market observational study is to evaluate the short-term effectiveness of the Simeox 200 airway clearance device in improving airway clearance in adult patients aged 18 to 85 with bronchiectasis and chronic mucus hypersecretion. The study aims to establish a baseline for wet sputum weight production using the Simeox 200 device. Additionally, the study aims to assess the short-term effects of Simeox 200 on various outcomes, including lung function, respiratory symptoms, and health-related quality of life.

Read full original descriptionShow less

The study participants will undergo the following steps:

1. Baseline Visit (V0): Participants will attend a baseline visit for eligibility screening, consent, a physical exam, and baseline assessments of various relevant parameters such as lung function, SpO2, and Patient-Reported-Outcomes. 2. Treatment Sessions (V1): Participants will perform two supervised treatment sessions with the Simeox 200 device at the clinic, during which sputum will be collected and weighed. 3. Home Use : Participants will use the device at home twice daily for 2 weeks, recording their usage and symptoms in a daily electronic diary. 4. Final Clinic Visit (V2): Participants will return for a final clinic visit for repeat assessments. 5. Follow-up Phone Call (14 days after V2): Participants will receive a follow-up phone call to assess ongoing symptoms and health status.