Recruiting

Observational StudySTRIVE Post-Market Registry Study

Sponsor:

Olympus Corporation of the Americas

Code:

NCT04302272

Conditions

Emphysema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Spiration Valve System (SVS)

Study Details

Brief 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.

Conditions

Emphysema

Study ID

NCT04302272

Start date

Oct 9, 2021

Status verified date

Apr, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.
2. Subjects must understand and voluntarily sign an informed consent form.

Exclusion Criteria:

1. Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements.
2. Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.
3. Subjects who have incomplete screening or baseline data.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

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 ]
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 ]

Central Contacts and Locations

Central contacts

Courtney Inge

703-201-0680 courtney.inge@olympus.com

Sharon Rabine

479-644-7840 sharon.rabine@olympus.com

Locations

Dignity Health St. Joseph's Hospital and Medical Center

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Gabrielle Ambrose

6024068875 gabrielle.ambrose@commonspirit.org

Principal Investigator:

Abid Khokar, MD

El Camino, Taft Center for Clinical Research

Recruiting

Mountain View, California, United States, 94040

Contacts

Winston Ku

650-962-4623 winston_ku@elcaminohealth.org

Principal Investigator:

Ganesh Krishna, MD

University of Miami

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Tiffany Salcito

tns93@med.miami.edu

Maria McCoy

mcm456@med.miami.edu

Principal Investigator:

Trishul Siddharthan, MD

Northwestern University, Division of Pulmonary and Critical Care Medicine

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Adriana Martinez

312-926-6680 adriana.martinez@northwestern.edu

Principal Investigator:

Momen Wahidi, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Vanita Patel

7737021012 vpatel4@bsd.uchicago.edu

Principal Investigator:

Kyle Hogarth, MD

LSU Health Shreveport

Recruiting

Shreveport, Louisiana, United States, 71130

Contacts

Teresa Leeth

318-675-7298 teresa.leeth@lsuhs.edu

Principal Investigator:

Robert Holladay, MD

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Kevin Yin

410-328-0410 kyin@som.umaryland.edu

Principal Investigator:

Ashutosh Sachdeva, MD

Beth Israel Decaconess

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Laith Ayasa

layassa@bidmc.harvard.edu

Principal Investigator:

Adnan Majid, MD

Memorial Hospital at Gulfport

Recruiting

Gulfport, Mississippi, United States, 39501

Contacts

Emily Hughes

228-867-4998 ehughes@mhg.com

Krista Casey

228-575-1825 krcasey@mhg.com

Principal Investigator:

Bobby Tullos, MD

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Jessica Shier

919-668-9139 jessica.shier@duke.edu

Principal Investigator:

Coral Giovacchini, MD

Penn State Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Karen Bright

7175310003 kbright@pennstatehealth.psu.edu

Principal Investigator:

Michael Reed, MD

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Helga Criner

215-707-1559 Lii-Yoong.Criner@tuhs.temple.edu

Principal Investigator:

Gerard Criner, MD

AnMed Health

Recruiting

Anderson, South Carolina, United States, 29621

Contacts

Melissa Frankum

864-512-8734 Melissa.Frankum@anmed.org

Principal Investigator:

Abhijit Raval, MD

Baylor Scott & White Research Institute

Recruiting

Dallas, Texas, United States, 75204

Contacts

Melyssa Monge

817-709-1066 Melyssa.Monge@BSWHealth.org

Principal Investigator:

Kumar Abhishek, MD

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Khyati Vadera

214-645-8000 Khyati.Vadera@utsouthwestern.edu

Principal Investigator:

Muhanned Abu-Hijleh, MD

More Information

Sponsor

Olympus Corporation of the Americas

Last update posted

Aug 3, 2026

Last verified

Apr, 2026

Keywords

Emphysema
Chronic obstructive pulmonary disease (COPD)
Spiration valve system

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-04. This information was provided to ClinicalTrials.gov by Olympus Corporation of the Americas on 2026-08-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.