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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Intermittent intrapulmonary deflation
DeviceTwo treatment sessions daily for two weeks
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Simeox 200Experimental treatment 1 intervention
Trial outcomes
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.
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.Secondary outcomes
1
Change from baseline in Forced Expiratory Volume in One seconde (FEV1) at the final study visit (V2) after 14 days of treatment
FEV1will be measured with a spirometer according to the ATS guidelines immediately before any procedures at the study site
Time frame
From enrollment to the final study visit at 15 days2
Change from baseline in Forced Vital Capacity (FVC) at the final study visit after 14 days of treatment
FVC will be measured with a spirometer according to the ATS guidelines immediately before any procedures at the study site
Time frame
From enrollment to the final study visit at 15 days3
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
FEF25-75% will be measured with a spirometer according to the ATS guidelines immediately before any procedures at the study site
Time frame
From enrollment to the final study visit at 15 days4
Change from baseline in Peripheral blood oxygen saturation (SpO2) at final study visit after 14 days of treatment
SpO2 will be measured transcutaneously at rest with a fingertip pulse oximeter before lung function measurements at rest and any procedures with the device at the study site
Time frame
From enrollment to the final study visit at 15 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: