Simeox 200 US Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorInogen Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Intermittent intrapulmonary deflation

Treatment groups

35 Participants
are divided into 1 treatment group

Sponsors and collaborators