A Multi Center Study Testing a New Implant for Adults With Severe Emphysema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorPulmair Medical, Inc.
About this trial
A study taking place at multiple sites in the United States, Europe and Brazil to evaluate how well a new therapy for severe COPD/emphysema works, and how safe it is.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed Informed Consent.
Diagnosis of COPD/emphysema.
At least 22-years of age.
18 ≤ BMI ≤ 32.
Disqualifiers
1. Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment..
Large bullae encompassing greater than 30% of either lung
Insufficient landmarks to evaluate the CT study using the software as it is intended
All lobes are less than 25% parenchyma diseased (< -950 HU) 15. Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant.
Trial design
Design model
Single group
Treatments tested in this trial
Implantable Artificial Bronchus
DeviceThe Implantable Artificial Bronchus (IAB) is a tapered, flexible and fenestrated polymer-based airway stent that is implanted bronchoscopically using a proprietary delivery system into diseased lungs of patients with emphysema.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: All subjects will receive study treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Absolute change in residual volume (RV)
The primary endpoint is the absolute change in residual volume (RV) from baseline to endpoint as recorded 90-days after the last implant.
Time frame
90 days after last IAB is implantedSecondary outcomes
1
Changes from baseline to 90-days, involving pulmonary function, exercise tolerance, dyspnea burden and occurrence as well as all related adverse device effects
Absolute change in Forced Expiratory Volume in one second (FEV1) from baseline to endpoint; Absolute change in residual volume/total lung capacity (RV/TLC) from baseline to endpoint; Absolute change in Six-minute Walk Distance (6MWD); Absolute change in the St George's Respiratory Questionnaire (SGRQ) total score where a higher score represents more significant impact of the disease on wellbeing; Absolute change in the Modified Medical Research Counsel Questionnaire (mMRC) dyspnea score; Absolute changes in COPD Assessment Test (CAT), with higher scores indicating a greater impact of COPD on health; Absolute change in EQ-5D Summary Index Questionnaire which measures self-reported assessment of mobility, self-care, usual activities, pain/discomfort and anxiety/depression with a higher score indicating more significant impact of the disease on each dimension. Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs) and Device Deficiencies (DDs) with SADE potential
Time frame
90 days after last implantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov