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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04302272
Other study ID # 17
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 9, 2021
Est. completion date April 2028

Study information

Verified date April 2024
Source Olympus Corporation of the Americas
Contact Lauri DeVore
Phone (425) 373-6802
Email lauri.devore@olympus.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date April 2028
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll. 3.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


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
United States AnMed Health Anderson South Carolina
United States Beth Israel Decaconess Boston Massachusetts
United States University of Chicago Chicago Illinois
United States Baylor Scott & White Research Institute Dallas Texas
United States University of Texas Southwestern Dallas Texas
United States Duke University Medical Center Durham North Carolina
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
United States El Camino, Taft Center for Clinical Research Mountain View California
United States Temple University Philadelphia Pennsylvania
United States Dignity Health St. Joseph's Hospital and Medical Center Phoenix Arizona
United States LSU Health Shreveport Shreveport Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Olympus Corporation of the Americas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Targeted lobe volume reduction (TLVR) Target lobe volume reduction (TLVR) determined from quantitative High-Resolution Computed Tomography (HRCT) at 6 months 6 months
Other Hyperinflation It will be measured by the ratio of residual volume to total lung capacity (RV/TLC) using plethysmography from baseline 6 and 12 months
Other Forced expiratory volume in 1 second (FEV1) Relative (percentage) change from baseline at 6, 12, 24 and 36 months 6, 12, 24 and 36 months
Other Modified Medical Research Council (mMRC) change Modified Medical Research Council (mMRC) change from baseline at 6, 12, 24 and 36 months 6, 12, 24 and 36 months
Other St. George's Respiratory Questionnaire (SGRQ) change St. George's Respiratory Questionnaire (SGRQ) change from baseline at 6, 12, 24 and 36 months 6, 12, 24 and 36 months
Other 6 Minute Walk Test (6MWT) change 6-minute walk test (6MWT) change from baseline at 6 and 12 months 6 and 12 months
Other 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 6 and 12 months
Other Responder Rates based on Minimum Clinically Important Difference (MCID) Responder rates based on Minimum Clinically Important Difference (MCID) for Effectiveness Observations 3 years
Primary 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. 12 months
Primary 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. 36 months
Secondary 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. 45 days
Secondary Survival rate over 24 months Survival rate over 24 months compared to the EMPROVE study control cohort 24 months
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