An observational study in Emphysema, sponsored by Olympus Corporation of the Americas. Recruiting at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Olympus Corporation of the Americas (part of Olympus Corporation) · Observational
This is a single-arm, prospective, multi-center, Registry study to evaluate the long-term safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe emphysema in a post-market setting.
This post-market study is a single-arm, prospective, multi-center Registry. It is designed to assess 36-month safety and effectiveness of this FDA approved product in a post-approval setting, and to support the continued assessment of Spiration Valve System therapy for the treatment of severe emphysema in the United States.
Subjects who are eligible and consent to be in this study, will be monitored for outcome data from baseline through 3 years post-first implant.
382 studies on the registry are indexed under Emphysema; 59 are open to participants now.
This study's planned enrollment of 150 is above the median of 131 across 111 observational studies indexed under Emphysema.
Browse 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.
Adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Spiration Valves are one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation. The Spiration Valve is loaded in the deployment catheter, then passed through the channel of a flexible bronchoscope and deployed at the intended target location. The SVS device is designed to relieve the symptoms of shortness of breath and hyperinflation associated with severe emphysema without surgery.
Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure
The primary safety endpoint will be the incidence of device-related and procedure-related pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure.
Time frame: 12 months
Rate (per patient-year) of pre-specified thoracic adverse events of special interest (TAEsSI) through 36 months following the first implantation procedure
An additional analysis will present the rate (per patient-year) of TAEsSI.
Time frame: 36 months
45-day pneumothorax rate
45-day pneumothorax rate, defined as pneumothorax requiring surgical intervention, or prolonged air leak \> 7 days defined as the time from chest tube insertion to the time the air leak is not present.
Time frame: 45 days
Survival rate over 24 months
Survival rate over 24 months compared to the EMPROVE study control cohort
Time frame: 24 months
Targeted lobe volume reduction (TLVR)
Target lobe volume reduction (TLVR) determined from quantitative High-Resolution Computed Tomography (HRCT) at 6 months
Time frame: 6 months
Hyperinflation
It will be measured by the ratio of residual volume to total lung capacity (RV/TLC) using plethysmography from baseline
Time frame: 6 and 12 months
Forced expiratory volume in 1 second (FEV1)
Relative (percentage) change from baseline at 6, 12, 24 and 36 months
Time frame: 6, 12, 24 and 36 months
Modified Medical Research Council (mMRC) change
Modified Medical Research Council (mMRC) change from baseline at 6, 12, 24 and 36 months
Time frame: 6, 12, 24 and 36 months
St. George's Respiratory Questionnaire (SGRQ) change
St. George's Respiratory Questionnaire (SGRQ) change from baseline at 6, 12, 24 and 36 months
Time frame: 6, 12, 24 and 36 months
6 Minute Walk Test (6MWT) change
6-minute walk test (6MWT) change from baseline at 6 and 12 months
Time frame: 6 and 12 months
Body Mass, Airflow Obstruction, Dyspnea and Exercise Capacity (BODE) Index change
Body mass, Airflow Obstruction, Dyspnea and Exercise Capacity (BODE) Index change from baseline at 6 and 12 months
Time frame: 6 and 12 months
Responder Rates based on Minimum Clinically Important Difference (MCID)
Responder rates based on Minimum Clinically Important Difference (MCID) for Effectiveness Observations
Time frame: 3 years
Started Oct 2021 (actual). Primary completion is estimated for Dec 2026, 62 months after the start.
Of 45 observational studies under Emphysema, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 35. This study's planned 62 months is close to that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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