NCT07443124

Simeox 200 US Study

A Pilot Study to Assess the Effects of Simeox 200 Airway Clearance Device in Bronchiectasis Patients With Chronic Mucus Hypersecretion

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Inogen Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Airway clearance techniques (ACTs) are essential for removing excess bronchial secretions and preventing airway complications. However, their effectiveness relies on patient adherence and satisfaction. Simoex 200 is a novel airway clearance device that uses intermittent negative oscillating pressure to mobilize airway secretions from different parts of the lungs to central airways, facilitating expectoration. Preliminary studies in Europe on patients with chronic muco-obstructive lung diseases have demonstrated the effectiveness and good tolerance of previous generations of the device. This pilot study will evaluate the Simeox 200 device in a home care setting for patients with bronchiectasis and excessive mucus production. The results of this study will inform a future larger-scale clinical trial.

Conditions

• Bronchiectasis
• Mucus; Plug

Interventions

Type	Name	Description
DEVICE	Intermittent intrapulmonary deflation	Two treatment sessions daily for two weeks

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study