STRIVE Post-Market Registry Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Olympus Corporation of the Americas
Study ID
NCT04302272
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Oct 9, 2021
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Oct 31, 2029

Study Design

Enrollment
150 participants (estimated)

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 ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Dignity Health St. Joseph's Hospital and Medical CenterPhoenixArizona85013
Gabrielle Ambrose
[email protected]
602-406-8875
Abid Khokar, MD (PRINCIPAL_INVESTIGATOR)
El Camino, Taft Center for Clinical ResearchMountain ViewCalifornia94040
Winston Ku
[email protected]
650-962-4623
Ganesh Krishna, MD (PRINCIPAL_INVESTIGATOR)
Harpreet Singh, MD (SUB_INVESTIGATOR)
University of MiamiCoral GablesFlorida33146
Tiffany Salcito
[email protected]
Maria McCoy
[email protected]
Trishul Siddharthan, MD (PRINCIPAL_INVESTIGATOR)
Northwestern University, Division of Pulmonary and Critical Care MedicineChicagoIllinois60611
Adriana Martinez
[email protected]
312-926-6680
Momen Wahidi, MD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Vanita Patel
[email protected]
773-702-1012
Kyle Hogarth, MD (PRINCIPAL_INVESTIGATOR)
LSU Health ShreveportShreveportLouisiana71130
Teresa Leeth
[email protected]
318-675-7298
Robert Holladay, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel DecaconessBostonMassachusetts02215
Adnan Majid, MD (PRINCIPAL_INVESTIGATOR)
Memorial Hospital at GulfportGulfportMississippi39501
Emily Hughes
[email protected]
228-867-4998
Krista Casey
[email protected]
228-575-1825
Bobby Tullos, MD (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710
Jessica Shier
[email protected]
919-668-9139
Coral Giovacchini, MD (PRINCIPAL_INVESTIGATOR)
Penn State Milton S. Hershey Medical CenterHersheyPennsylvania17033
Karen Bright
[email protected]
717-531-0003
Michael Reed, MD (PRINCIPAL_INVESTIGATOR)
Temple UniversityPhiladelphiaPennsylvania19140
Helga Criner
[email protected]
215-707-1559
Gerard Criner, MD (PRINCIPAL_INVESTIGATOR)
AnMed HealthAndersonSouth Carolina29621
Melissa Frankum
[email protected]
864-512-8734
Abhijit Raval, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White Research InstituteDallasTexas75204
Melyssa Monge
[email protected]
817-709-1066
Kumar Abhishek, MD (PRINCIPAL_INVESTIGATOR)
Gary Schwartz, MD (SUB_INVESTIGATOR)
University of Texas SouthwesternDallasTexas75390
Khyati Vadera
[email protected]
214-645-8000
Muhanned Abu-Hijleh, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By condition
COPD
By specialty
PulmonologyLung disease
By research site
Dignity Health St. Joseph's Hospital and Medical Center· Phoenix, AZEl Camino, Taft Center for Clinical Research· Mountain View, CAUniversity of Miami· Coral Gables, FLNorthwestern University, Division of Pulmonary and Critical Care Medicine· Chicago, ILUniversity of Chicago· Chicago, ILLSU Health Shreveport· Shreveport, LA

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