Simeox 200 US Study

NCT07443124 | Not Yet Recruiting FDA Device

• 1 other identifier: SIM200-NCFB-1001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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. 4.Final Clinic Visit (V2): Participants will return for a final clinic visit for repeat assessments.
5. 5.Follow-up Phone Call (14 days after V2): Participants will receive a follow-up phone call to assess ongoing symptoms and health status.

Conditions

Bronchiectasis; Mucus; Plug

Keywords

Bronchiectasis; Mucus hypersecretion; Airway clearance technique; Bronchial drainage

Outcome Measures

Primary Outcomes (1)

• Wet sputum weight collected with Simeox 200 during device training visit

  Patients will be instructed during device training visit (V1) to spill all sputum into a pre-weighed pot from at least two supervised sessions. Immediately after collection, all sputum will be weighed on weighing scales with an accuracy of 0.01 grams.

  From the first training session to the last, and up to one hour following each treatment session the day of training device visit.

Secondary Outcomes (11)

• Change from baseline in Forced Expiratory Volume in One seconde (FEV1) at the final study visit (V2) after 14 days of treatment

  From enrollment to the final study visit at 15 days

• Change from baseline in Forced Vital Capacity (FVC) at the final study visit after 14 days of treatment

  From enrollment to the final study visit at 15 days

• Change from baseline in Forced Expiratory Flow between 25% and 75% of vital capacity (FEF25-75%) at the final study visit after 14 days of treatment

  From enrollment to the final study visit at 15 days

• Change from baseline in Peripheral blood oxygen saturation (SpO2) at final study visit after 14 days of treatment

  From enrollment to the final study visit at 15 days

• Change from baseline in perceived respiratory symptoms assessed with the Breathlessness, Cough and Sputum Scale (BCSS) at 7 and 14 days of treatment

  From enrollment to 7 and 14 days of treatment at home

Study Arms (1)

Simeox 200

EXPERIMENTAL

Simeox 200 airway clearance device

Device: Intermittent intrapulmonary deflation

Interventions

Intermittent intrapulmonary deflation DEVICE

Two treatment sessions daily for two weeks

Simeox 200

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• History of pneumothorax within the prior 6 months
• History of haemoptysis treated with embolization within the prior 12 months
• Inability to use airway clearance therapy as directed
• Unable or unwilling to complete study visits or provide follow-up data as required per the study protocol

Sponsors & Collaborators

• Inogen Inc.: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Patrick A Flume, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roxanna Edwards

CONTACT

xxx-xxx-xxxx; redwards@inogen.net

Chief Medical Officer

CONTACT

kjhaveri@inogen.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 2, 2026
• Study Start: February 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: June 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (1)