Simeox 200 US Study

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Inogen Inc.
Study ID
NCT07443124
Status
Not Yet Recruiting

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Conditions

  • Bronchiectasis
  • Mucus; Plug

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Intermittent intrapulmonary deflation — DEVICE
    Two treatment sessions daily for two weeks

Study Details

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.

Key Dates

Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
May 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Simeox 200
    Simeox 200 airway clearance device

Primary Outcome Measure

Wet sputum weight collected with Simeox 200 during device training visit [ Time Frame: From the first training session to the last, and up to one hour following each treatment session the day of training device visit. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Patrick A Flume, MD
xxx-xxx-xxxx

Find similar trials in Charleston, SC

By research site
Medical University of South Carolina· Charleston, SC

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