Emphysema
Conditions
Brief summary
This is a multicenter, prospective study designed to evaluate performance of the SVS in the REACH SVS control patients. The study is expected to enroll up to 20 patients at up to 12 sites with up to 6 patients per site.
Interventions
DEVICESpiration Valve System
Sponsors
Olympus Corporation of the Americas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient was enrolled in the REACH SVS Study control group and has completed their participation in the Study including the 12 month follow-up visit. * Patient has received standard-of-care medical management and it has been stable for 6 weeks. * Patient is willing to participate in a study, complete the required follow-up visits, and maintain consistent nutrition and exercise habits during the study period.
Exclusion criteria
* Patient is classified as ASA Class greater than P4 including presence of co-morbidity that could significantly increase the risk of a bronchoscopy procedure. * Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study. * Patient has demonstrated unwillingness or inability to complete baseline data collection procedures. * Patient has co-existing major medical disease that will limit evaluation, participation, or follow-up in the study. * Patient is unable to provide informed consent. * Patient is not an appropriate candidate for or is unable to tolerate, flexible bronchoscopy procedures. * Patient has history of 4 or more hospitalizations for COPD exacerbation or respiratory infections in the past year and none have occurred in the prior 3 months. * Patient has evidence of systemic disease or neoplasia expected to compromise survival during the 3-month study period * Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forced expiratory volume at 1 second | Three months |
Countries
China
Outcome results
None listed