An interventional study of Spiration Valve System in Emphysema, sponsored by Olympus Corporation of the Americas. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2018-10-24.
Sponsored by Olympus Corporation of the Americas · Not applicable, Interventional, and Treatment
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.
187 studies on the registry are indexed under Pulmonary Emphysema; 19 are open to participants now.
This study's enrollment of 9 is below the median of 33 across 128 interventional studies indexed under Pulmonary Emphysema.
Browse Pulmonary Emphysema studies →Olympus Corporation of the Americas is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The treatment algorithm is complete occlusion of one lobe of the lung by using valves to occlude all segments of the lobe. The lobe will be selected based on imaging with high resolution computed tomography (HRCT). The lobe to be treated will have severe heterogeneous emphysema based on visual exam. The selected lobe will also have an intact fissure separation with the ipsilateral lobe. An intact fissure will be estimated visually to be ≥ 90% complete after viewing the HRCT in 3 dimensions. If more than one lobe meets criteria, the investigator will determine a primary lobe to treat based on fissure completeness, heterogeneity, disease severity, and the anatomy of the airways that will be treated.
Device: Spiration Valve System
Forced expiratory volume at 1 second
Time frame: Three months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Olympus Corporation of the Americas