The Spiration Valve System for the Treatment of Severe Emphysema

Olympus Corporation of the Americas12 sites in 1 country107 target enrollmentNovember 8, 2013

ConditionsEmpyhsema Pulmonary Disease, Chronic Obstructive

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Empyhsema
Sponsor: Olympus Corporation of the Americas
Enrollment: 107
Locations: 12
Primary Endpoint: Difference between treatment and control groups in the mean change in forced expiratory volume in one second (FEV1)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, prospective, randomized, controlled study being conducted in China to evaluate improvement of lung function after treatment with the Spiration Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group.

The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.

Registry

clinicaltrials.gov

Start Date

November 8, 2013

End Date

March 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Olympus Corporation of the Americas

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient has severe emphysema and high heterogeneity by visual assessment defined as:
•a target lobe with ≥ 40% emphysema involvement and
•≥ 15% difference with the ipsilateral lobe.
•The target lobe and ipsilateral lobe will be separated with an intact fissure. An intact fissure will be estimated visually to be ≥90% complete after viewing the HRCT in 3 dimensions.
•Patient has received optimal medical management and it has been stable for 6 weeks prior to baseline testing. If pulmonary rehabilitation has been recent, it will be completed at least 3 months prior to baseline testing.
•Patient must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of ≥ 140 m.
•Patient has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study.
•Severe dyspnea defined as a mMRC ≥
•Patient's obstructive disease is severe as defined by:
•FEV1 ≤ 45% of predicted

Exclusion Criteria

•Patient has severe gas exchange abnormalities as defined by:
•PCO2 \> 50 mm Hg (6.6 kPa), or
•PaO2 \< 45 mm Hg (6.0 kPa) on room air
•Patient has a BMI \< 15 kg/m2 or \> 35 kg/m2
•Patient is unable to provide informed consent.
•Patient is not an appropriate candidate for or is unable to tolerate, flexible bronchoscopy procedures.
•Patient has dysrhythmia or cardiovascular disease that poses a risk during exercise.
•Patient has history of 4 or more hospitalizations for COPD exacerbation or respiratory infections in the past year or has had a COPD exacerbation in the 3 months prior to baseline testing.
•Patient has bronchitis with sputum production \> 60 ml per day.
•Patient has an active asthma component to their disease or requires more than 15 mg of prednisone daily (20 mg prednisolone).

Outcomes

Primary Outcomes

Difference between treatment and control groups in the mean change in forced expiratory volume in one second (FEV1)

Time Frame: Baseline and 3 Months

Secondary Outcomes

Incidence of device-related serious adverse events(Baseline and 3 Months)
Difference between responder rates in the treatment and control groups, with a responder defined as ≥ 15% improvement in FEV1(Baseline and 3 Months)
Target lobe volume reduction as measured by QCT(Baseline and 3 Months)
Health Status as measured by St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT)(Baseline and 3 Months)
Dyspnea as measured by Modified Medical Research Council Questionnaire (mMRC)(Baseline and 3 Months)
Exercise capacity as measured by Six Minute Walk Test (6MWT)(Baseline and 3 Months)
Hyperinflation as measured by Residual Volume (RV)(Baseline and 3 Months)