Pilot Study of the Spiration IBV™ System
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Emphysema
- Sponsor
- Olympus Corporation of the Americas
- Enrollment
- 91
- Locations
- 14
- Primary Endpoint
- The primary endpoint of this study is to evaluate the safety of the device, during deployment and short-term implantation for a period of up to 3 months.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The Spiration Intra-Bronchial Valve is intended for use as a minimally invasive treatment for severe emphysema, using standard bronchoscopy. The valve is designed to limit airflow to a selected portion of the lung, producing a reduction in lung volume, which may improve pulmonary function in patients with emphysema.
Detailed Description
This pilot study is an open enrollment, prospective study with each subject serving as their own control. The sponsor may attempt to include the data from this study in the statistical analysis of the pivotal study. This proposal shall be evaluated at the conclusion of the pilot study. PATIENT POPULATION Patients with severe emphysema are eligible to be screened for enrollment in this study. In this initial pilot study, eligible subjects will have severe, heterogeneous, predominantly upper lobe emphysema, as defined by the American Thoracic Society (ATS) 1 and the NETT Research Group.2 These subjects also will be patients who have been screened as potential candidates for LVRS, but who have been excluded from surgical treatment due to a failure to satisfy the inclusion and exclusion criteria established by the NETT Research Group for LVRS.2 Patients also will be able to tolerate a flexible bronchoscopy procedure. Patients who have been screened and accepted for a lung transplant procedure or LVRS, and are currently registered or scheduled for such a procedure, are not eligible for enrollment in this pilot study. Patients with an FEV1 \< 20% predicted and either homogeneous emphysema or DLCO \< 20% will be excluded from enrollment in this pilot study.3 Patients will be screened and enrolled until up to 115 subjects have undergone treatment with the IBV System. Up to 15 clinical centers will be selected to enroll and treat subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and Female subjects at least 18 years of age.
- •Subject has severe, heterogeneous, predominantly upper lobe emphysema.
- •Subject has ability to meet goals of, or currently satisfies goals of, a comprehensive pulmonary rehabilitation program.
- •Subject has satisfied requirement for post-rehabilitation 6-minute walk of ≥ 140 m 6 and is able to complete 3 min unloaded pedaling in exercise tolerance test.
- •Subject has abstained from cigarette smoking for 4 months, as confirmed by urine or serum cotinine test.
- •Pulmonary function testing results demonstrate:
- •FEV1 ≤ 45% predicted (≥ 15% predicted if age ≥ 70 years)
- •TLC ≥ 100% predicted
- •RV ≥ 150% predicted
- •Arterial blood gas level indicates:
Exclusion Criteria
- •Patients with FEV1\< 20% predicted and either homogeneous emphysema or DLCO \< 20%. 3
- •Subject is unable to provide informed consent.
- •Subject is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures.
- •Subject has dysrhythmia that might pose a risk during exercise or training.
- •Subject has resting bradycardia (\< 50 beats/min); frequent multifocal PVCs; complex ventricular arrhythmia; sustained SVT.
- •Subject has history of exercise-related syncope.
- •Subject has uncontrolled hypertension (systolic, \> 200 mm; diastolic \> 110 mm).
- •Subject has history of recurrent infections with clinically significant sputum production
- •Subject has known, active asthma, chronic bronchitis or clinically significant bronchiectasis.
- •Subject has giant bulla (\> 1/3 volume of lung).
Outcomes
Primary Outcomes
The primary endpoint of this study is to evaluate the safety of the device, during deployment and short-term implantation for a period of up to 3 months.
Secondary Outcomes
- The secondary endpoint is to estimate the effectiveness achieved after 1 and 3 months of use.