A Multicenter, Prospective, Single-Arm Clinical Investigation of a Modified Staged Treatment Algorithm Using the AeriSeal System - the AeriSeal-STAGE Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Emphysema
- Sponsor
- Pulmonx Corporation
- Enrollment
- 14
- Locations
- 4
- Primary Endpoint
- Incidence of Serious Adverse Events
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
A multicenter, prospective, single-arm clinical investigation to evaluate the short term and long term safety of a modified staged treatment algorithm using the AeriSeal System.
Detailed Description
The AeriSeal-STAGE trial will be a prospective, multicenter study that intends to evaluate the safety of a modified staged treatment algorithm with an escalation of dose using the AeriSeal System in the treatment of subjects with severe emphysema in a controlled trial design setting as compared to published data from prior studies. The trial is anticipated to enroll fifteen (15) study subjects with homogeneous, or upper lobe predominant heterogeneous emphysema, in three (3) centers in Europe.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is willing and able to provide informed consent and to participate in the study
- •Subject is ≥ 40 years of age
- •Subject has a diagnosis of homogenous or heterogeneous upper lobe predominant emphysema confirmed by computerized tomography (CT) scan.
- •Subject has at least two (2) non-adjacent subsegments appropriate for treatment based upon CT scan in 2 different upper lobe segments in each lung (total 4 available subsegments)
- •Subject has clinically significant dyspnea scoring \>1 on the mMRC scale of 0 - 4
- •Subject has a Six-Minute Walk Test (6MWT) distance ≥ 250 meters
- •Subject has post-bronchodilator FEV1 ≤ 45% predicted
- •Subject has Total Lung Capacity \>100% predicted
- •Subject has Residual Volume \>175% predicted
- •Subject has stopped smoking for at least 8 weeks prior to entering the study as confirmed by carboxyhemoglobin or cotinine levels
Exclusion Criteria
- •Subject has severe bullous emphysema as judged by Investigator.
- •Subject has prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any type
- •Subject has evidence of active respiratory infection
- •Subject has an ongoing chronic obstructive pulmonary disease (COPD) exacerbation or bronchospasm
- •Subject has a known allergy to the device components:
- •Polyether block amide - PEBAX®
- •Polyvinyl Alcohol
- •Glutaraldehyde
- •Subject requires ventilatory support (invasive or non-invasive)
- •Subject has diffusing capacity of the lungs for carbon monoxide (DLco) \< 20% predicted
Outcomes
Primary Outcomes
Incidence of Serious Adverse Events
Time Frame: 3-months post treatment period
Assessment of Serious Adverse Events (SAEs) To evaluate the safety of using a modified staged treatment algorithm at 3- months following the second placement of AeriSeal foam treatment in subjects with severe emphysema. The primary endpoint will be safety of AeriSeal System treatment. Safety will be assessed by monitoring the incidence of Serious Adverse Events (SAEs), during the 3-months post treatment period. Exclusively, the incidence of a prospectively specified subset of important respiratory related SAEs (COPD exacerbations requiring hospitalization or extended hospitalization, pneumonia, acute inflammatory response occurring after 30-days posttreatment, pneumothoraces), deaths and respiratory failures will be lower as compared to published data from prior studies.
Secondary Outcomes
- Forced Expiratory Volume in one second (FEV1)(Baseline, 3-months, 6-months and 12-months)
- Residual volume (RV)(Baseline, 3-months, 6-months and 12-months)
- Exercise capacity as assessed by six-minute walk test (6MWT)(Baseline, 3-months, 6-months and 12-months)
- Quality of life as assessed by the St George's Respiratory Questionnaire (SGRQ)(Baseline, 3-months, 6-months and 12-months)
- Dyspnea as assessed by the Modified Medical Research Council Dyspnea Score (mMRC)(Baseline, 3-months, 6-months and 12-months)
- Lobar volume reduction(3-months)
- Radiological signs of complications on computerized tomography (CT) scans(3-months following the second placement of AeriSeal foam.)