Evaluation of the Spiration® Valve System for Emphysema to Improve Lung Function

Emphysema Clinical Trial

— EMPROVE  

Official title:

A Prospective, Randomized, Controlled Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Spiration® Valve System for the Single Lobe Treatment of Severe Emphysema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01812447
• Other study ID #: CPR-03434
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: August 2022

Study information

• Verified date: March 2023
• Source: Spiration, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

EMPROVE is a multicenter, prospective, randomized, controlled study designed to evaluate the safety and long-term effectiveness of the Spiration Valve System in patients with emphysema. Patients appropriate for the EMPROVE study are those who are currently on medical treatment but still symptomatic. EMPROVE also accepts α-1 antitrypsin deficiency patients.

Description:

The Spiration Valve is a small, one-way valve that is used to block air from entering diseased portions of the lung. This helps to reduce the volume in diseased lung due to hyperinflation. Volume reduction of diseased lung has been shown to improve lung function and other quality of life measures for people living with emphysema. The Spiration Valve is placed in the diseased section of the lungs using a tool called a bronchoscope. A bronchoscope is a small tube that has a camera on the end. The bronchoscope enters the lungs through the mouth. The Spiration Valve is delivered and placed in the targeted airways via another thin tube called a catheter that travels through the bronchoscope. - Once in place, the Spiration Valve expands and contracts with breathing, creating a complete seal around the airway - The seal blocks air from entering the target lobe while at the same time allowing trapped air and fluids to escape. - This causes the diseased (hyper-inflated) lung to reduce in volume or collapse - Studies have shown volume reduction may allow healthier lung to function better - More information and a description of the Spiration Valve System can be found on the EMPROVE clinical trial website, www.EmphysemaTrial.com Safety and outcomes of the Spiration Valve System in emphysema have been published in several peer-reviewed journals. The articles listed below represent a summary of existing literature regarding the use of the Spiration Valve System for the treatment of emphysema. The selected articles are being provided to help understand the body of data describing the use of the Spiration Valve System. 1. Unilateral Versus Bilateral Endoscopic Lung Volume Reduction: A Comparative Case Study, NCT00995852 Eberhardt R, Gompelmann D, Schuhmann M, Heussel CP, Herth FJ. Complete unilateral vs partial bilateral endoscopic lung volume reduction in patients with bilateral lung emphysema. Chest. 2012 Oct;142(4):900-908 2. Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema (IBV®Valve), NCT00475007 Wood DE, Nader DA, Springmeyer SC, Elstad MR, Coxson HO, Chan A, Rai NS, Mularski RA, Cooper CB, Wise RA, Jones PW, Mehta AC, Gonzalez X, Sterman DH; IBV Valve Trial Research Team. The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema. J Bronchology Interv Pulmonol. 2014 Oct;21(4):288-297 3. European Multi-Center Post Market Study of the IBV Valve System, NCT00880724 Ninane V, Geltner C, Bezzi M, Foccoli P, Gottlieb J, Welte T, Seijo L, Zulueta JJ, Munavvar M, Rosell A, Lopez M, Jones PW, Coxson HO, Springmeyer SC, Gonzalez X. Multicentre European study for the treatment of advanced emphysema with bronchial valves. Eur Respir J. 2012 Jun;39(6):1319-1325

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: August 2022
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Subject has severe and heterogeneous emphysema with severe dyspnea
• Subject certified to meet the criteria of ATS/ERS guidelines for management of stable COPD
• Subject must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of = 140 m
• Subject has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study
• Pulmonary Function Testing Results (PFT's) demonstrate:
• FEV1 = 45% of predicted
• RV = 150% of predicted
• TLC = 100% of predicted

Exclusion Criteria:

• Patient has a BMI < 15 kg/m2
• Arterial Blood Gas Level (ABG) indicates:
• PCO2 > 55 mm Hg
• PO2 < 45 mm Hg on room air
• Subject has a diffuse emphysema pattern
• Subject has bronchitis with sputum production > 4 Tablespoons or 60 ml per day
• Subject has an active asthma (>15 mg of prednisone daily)
• Giant bulla (> 1/3 volume of lung)
• Pulmonary hypertension
• Subject with prior major lung surgery or recent hospitalization for COPD exacerbation or respiratory infections

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Device:
• Spiration Valve System
Subjects assigned to the treatment group will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe.

Other:
• Medical Management
Stable management is based on the ACP/ACCP/ATS/ERS Guidelines for Management of Stable COPD. Medical management will include management of COPD medications, oxygen use, and pulmonary rehabilitation.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Laval University	Québec	Quebec
United States	Piedmont Hospital	Atlanta	Georgia
United States	University of Maryland	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Fletcher Allen Medical Center	Burlington	Vermont
United States	Lahey Clinic	Burlington	Massachusetts
United States	Cooper University Hospital	Camden	New Jersey
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Kaiser Permanente Northwest Medical Center	Clackamas	Oregon
United States	UT Southwestern Medical Center at Dallas	Dallas	Texas
United States	Beaumont Botsford Hospital (DCRC)	Farmington Hills	Michigan
United States	Sparks Regional Medical Center	Fort Smith	Arkansas
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Michael DeBakey VA Medical Center	Houston	Texas
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Miami VA Healthcare System	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Cornell NYPH	New York	New York
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Kaiser Permanente Riverside Medical Center	Riverside	California
United States	University of Utah	Salt Lake City	Utah
United States	University of California San Diego	San Diego	California
United States	California Pacific Medical Center	San Francisco	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Louisiana State University Hospital	Shreveport	Louisiana
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Spiration, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Criner GJ, Delage A, Voelker K, Hogarth DK, Majid A, Zgoda M, Lazarus DR, Casal R, Benzaquen SB, Holladay RC, Wellikoff A, Calero K, Rumbak MJ, Branca PR, Abu-Hijleh M, Mallea JM, Kalhan R, Sachdeva A, Kinsey CM, Lamb CR, Reed MF, Abouzgheib WB, Kaplan PV — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of thoracic SAEs		Baseline and 6 months
Primary	The primary effectiveness endpoint will be the difference between the treatment and control groups in the mean change in forced expiratory volume in 1 second (FEV1)		Baseline and 6 Months
Secondary	Target lobe volume reduction as measured by QCT		Baseline and 6 Months
Secondary	Hyperinflation as measured by the ratio of Residual Volume to Total Lung Capacity (RV/TLC)		Baseline and 6 Months
Secondary	Health Status as measured by St. George's Respiratory Questionnaire (SGRQ)		Baseline and 6 Months
Secondary	Dyspnea as measured by Modified Medical Research Council Questionnaire (mMRC)		Baseline and 6 Months
Secondary	Exercise capacity as measured by Six Minute Walk Test (6MWT)		Baseline and 6 Months
Secondary	FEV1 Responders, defined as those achieving at least 15% improvement from baseline		Baseline and 6 Months