EmphysemaNCT04302272
STRIVE Post-Market Registry Study
An observational study of Emphysema, run by Olympus Corporation of the Americas at 16 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emphysema
- What is being tested?
- Spiration Valve System (SVS)
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 16 sitesUnited States
- Study dates
- 9 Oct 2021to Oct 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation.
Who may be able to join
- Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.
- Subjects must understand and voluntarily sign an informed consent form.
Who cannot join
- Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements.
- Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.
- Subjects who have incomplete screening or baseline data.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
AnMed Health
Anderson, South Carolina, 29621
Melissa Frankum, 864-512-8734, Melissa.Frankum@anmed.org
Abhijit Raval, MD
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Kevin Yin, 410-328-0410, kyin@som.umaryland.edu
Ashutosh Sachdeva, MD
- Recruiting
Beth Israel Decaconess
Boston, Massachusetts, 02215
Laith Ayasa, layassa@bidmc.harvard.edu
Adnan Majid, MD
- Recruiting
Northwestern University, Division of Pulmonary and Critical Care Medicine
Chicago, Illinois, 60611
Adriana Martinez, 312-926-6680, adriana.martinez@northwestern.edu
Momen Wahidi, MD
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Vanita Patel, 7737021012, vpatel4@bsd.uchicago.edu
Kyle Hogarth, MD
- Recruiting
University of Miami
Coral Gables, Florida, 33146
Tiffany Salcito, tns93@med.miami.edu
Maria McCoy, mcm456@med.miami.edu
- Recruiting
Baylor Scott & White Research Institute
Dallas, Texas, 75204
Melyssa Monge, 817-709-1066, Melyssa.Monge@BSWHealth.org
Kumar Abhishek, MD
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
Khyati Vadera, 214-645-8000, Khyati.Vadera@utsouthwestern.edu
Muhanned Abu-Hijleh, MD
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Jessica Shier, 919-668-9139, jessica.shier@duke.edu
Coral Giovacchini, MD
- Recruiting
Memorial Hospital at Gulfport
Gulfport, Mississippi, 39501
Emily Hughes, 228-867-4998, ehughes@mhg.com
Krista Casey, 228-575-1825, krcasey@mhg.com
- Recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Karen Bright, 7175310003 ext. 285155, kbright@pennstatehealth.psu.edu
Michael Reed, MD
- Recruiting
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Tejinder Kaur, 832-282-7233, tejinder.kaur@uth.tmc.edu
Rahat Hussain, MD
- Recruiting
El Camino, Taft Center for Clinical Research
Mountain View, California, 94040
Winston Ku, 650-962-4623, winston_ku@elcaminohealth.org
Ganesh Krishna, MD
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19140
Helga Criner, 215-707-1559, Lii-Yoong.Criner@tuhs.temple.edu
Gerard Criner, MD
- Recruiting
Dignity Health St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Gabrielle Ambrose, 6024068875, gabrielle.ambrose@commonspirit.org
Abid Khokar, MD
- Recruiting
LSU Health Shreveport
Shreveport, Louisiana, 71130
Teresa Leeth, 318-675-7298, teresa.leeth@lsuhs.edu
Robert Holladay, MD
About this study
Official title: The Spiration® Valve System (SVS) Post-Market Registry Study for Severe Emphysema
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.
Read the detailed description
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.
- Conditions
- Emphysema
- Being tested
- Spiration Valve System (SVS)
- Keywords
- Emphysema, Chronic obstructive pulmonary disease (COPD), Spiration valve system
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiration Valve System (SVS)Device
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 36 months
Secondary outcomes (2)
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.
Measured: 45 days
Survival rate over 24 months
Survival rate over 24 months compared to the EMPROVE study control cohort
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start9 Oct 2021
- Primary completionDec 2026 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Olympus Corporation of the Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Criner, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302272
- Sponsor's protocol ID
- CPR-05644
- Status last verified
- Oct 2026
- First submitted
- 24 Feb 2020
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Spiration® Valve System (SVS) Post-Market Registry Study for Severe Emphysema
- ClinicalTrials.gov ID
- NCT04302272
- Acronym / sponsor ID
- CPR-05644
- Conditions
- Emphysema
- Keywords
- Emphysema, Chronic obstructive pulmonary disease (COPD), Spiration valve system
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Olympus Corporation of the AmericasIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation.
Key inclusion criteria (2 listed)
- Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.
- Subjects must understand and voluntarily sign an informed consent form.
Key exclusion criteria (3 listed)
- Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements.
- Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.
- Subjects who have incomplete screening or baseline data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spiration Valve System (SVS)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. | Device | – |
Primary outcome
Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure
Time frame: 12 months
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.
Rate (per patient-year) of pre-specified thoracic adverse events of special interest (TAEsSI) through 36 months following the first implantation procedure
Time frame: 36 months
An additional analysis will present the rate (per patient-year) of TAEsSI.
2 secondary outcomes
45-day pneumothorax rate
Time frame: 45 days
Survival rate over 24 months
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gerard Criner, MD principal investigator
Temple University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emphysema, run by Olympus Corporation of the Americas at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Inge (703-201-0680, courtney.inge@olympus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.