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Simeox 200 US Study

NCT07443124 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Intermittent intrapulmonary deflation

Two treatment sessions daily for two weeks

Sponsors & Collaborators

  • Inogen Inc.

    lead INDUSTRY

Principal Investigators

  • Patrick A Flume, MD · Medical University of South Carolina

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-05-31
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07443124 on ClinicalTrials.gov