Simeox 200 US Study (NCT07443124)
🩺 Plain-English Summary (8th-Grade Level)
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. 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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (17 items).
Location: Medical University of South Carolina — Charleston, South Carolina
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Inability to cough forcefully and independently, as determined by the clinician
- Ventilatory assistance with endotracheal tube, tracheostomy tube, or mask (not including nocturnal CPAP)
- 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)
- Hemodynamic instability, as determined by the clinician
- Airway at risk for aspiration, as determined by the clinician
- Uncontrolled gastroesophageal reflux disease (GERD) as determined by the clinician
- Upper airway surgery in the prior 3 months
- Cardiothoracic surgery, including esophageal surgery, in the prior 6 months
- Anticipated hospitalization within the next 2 weeks
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Medical University of South Carolina — Charleston, South Carolina
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.