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

Primary Purpose

Emphysema

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Spiration Valve System
Medical Management
Sponsored by
Olympus Corporation of the Americas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema focused on measuring Endobronchial Valves, Intrabronchial Valves, Bronchial Valve, Chronic Obstructive Pulmonary Disease, COPD, Pulmonary Disease, Chronic Obstructive, Bronchoscopic Lung Volume Reduction, BLVR, TLVR, Emphysema, Pulmonary Emphysema, Pathologic Process, Lung Diseases, Respiratory Tract Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sparks Regional Medical Center
  • Kaiser Permanente Riverside Medical Center
  • University of California San Diego
  • California Pacific Medical Center
  • Mayo Clinic Jacksonville
  • Miami VA Healthcare System
  • Sarasota Memorial Hospital
  • Tampa General Hospital
  • Piedmont Hospital
  • University of Chicago
  • Northwestern Memorial Hospital
  • Louisiana State University Hospital
  • University of Maryland
  • Beth Israel Deaconess Medical Center
  • Lahey Clinic
  • Beaumont Botsford Hospital (DCRC)
  • Cooper University Hospital
  • Cornell NYPH
  • Carolinas Medical Center
  • University of Cincinnati
  • Kaiser Permanente Northwest Medical Center
  • Penn State Milton S. Hershey Medical Center
  • Temple University Hospital
  • University of Pittsburgh Medical Center
  • University of Tennessee Medical Center
  • Vanderbilt University Medical Center
  • UT Southwestern Medical Center at Dallas
  • Michael DeBakey VA Medical Center
  • University of Utah
  • Fletcher Allen Medical Center
  • Virginia Commonwealth University
  • Medical College of Wisconsin
  • University of Calgary
  • Laval University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Spiration Valve System

Spiration Valve System, α-1

Medical Management

Arm Description

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. Subjects assigned to this group will also receive medical management.

α-1 antitrypsin deficiency subjects will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. Subjects assigned to this group will also receive medical management. There is no randomization for this group.

The control group for this study will receive medical management. This medical management group will be evaluated and followed in the same manner as the treatment group, but without having a bronchoscopic procedure.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Target lobe volume reduction as measured by QCT
Hyperinflation as measured by the ratio of Residual Volume to Total Lung Capacity (RV/TLC)
Health Status as measured by St. George's Respiratory Questionnaire (SGRQ)
Dyspnea as measured by Modified Medical Research Council Questionnaire (mMRC)
Exercise capacity as measured by Six Minute Walk Test (6MWT)
FEV1 Responders, defined as those achieving at least 15% improvement from baseline

Full Information

First Posted
March 7, 2013
Last Updated
March 21, 2023
Sponsor
Olympus Corporation of the Americas
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1. Study Identification

Unique Protocol Identification Number
NCT01812447
Brief Title
Evaluation of the Spiration® Valve System for Emphysema to Improve Lung Function
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
August 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Olympus Corporation of the Americas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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. 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 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema
Keywords
Endobronchial Valves, Intrabronchial Valves, Bronchial Valve, Chronic Obstructive Pulmonary Disease, COPD, Pulmonary Disease, Chronic Obstructive, Bronchoscopic Lung Volume Reduction, BLVR, TLVR, Emphysema, Pulmonary Emphysema, Pathologic Process, Lung Diseases, Respiratory Tract Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spiration Valve System
Arm Type
Experimental
Arm Description
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. Subjects assigned to this group will also receive medical management.
Arm Title
Spiration Valve System, α-1
Arm Type
Experimental
Arm Description
α-1 antitrypsin deficiency subjects will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. Subjects assigned to this group will also receive medical management. There is no randomization for this group.
Arm Title
Medical Management
Arm Type
Active Comparator
Arm Description
The control group for this study will receive medical management. This medical management group will be evaluated and followed in the same manner as the treatment group, but without having a bronchoscopic procedure.
Intervention Type
Device
Intervention Name(s)
Spiration Valve System
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Medical Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Time Frame
Baseline and 6 Months
Secondary Outcome Measure Information:
Title
Target lobe volume reduction as measured by QCT
Time Frame
Baseline and 6 Months
Title
Hyperinflation as measured by the ratio of Residual Volume to Total Lung Capacity (RV/TLC)
Time Frame
Baseline and 6 Months
Title
Health Status as measured by St. George's Respiratory Questionnaire (SGRQ)
Time Frame
Baseline and 6 Months
Title
Dyspnea as measured by Modified Medical Research Council Questionnaire (mMRC)
Time Frame
Baseline and 6 Months
Title
Exercise capacity as measured by Six Minute Walk Test (6MWT)
Time Frame
Baseline and 6 Months
Title
FEV1 Responders, defined as those achieving at least 15% improvement from baseline
Time Frame
Baseline and 6 Months
Other Pre-specified Outcome Measures:
Title
Incidence of thoracic SAEs
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sparks Regional Medical Center
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901
Country
United States
Facility Name
Kaiser Permanente Riverside Medical Center
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Miami VA Healthcare System
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60561
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Louisiana State University Hospital
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Beaumont Botsford Hospital (DCRC)
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Cornell NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Kaiser Permanente Northwest Medical Center
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
UT Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Michael DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Fletcher Allen Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Laval University
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
31365298
Citation
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, Marrujo GX, Johnstone DW, Gasparri MG, Meade AA, Hergott CA, Reddy C, Mularski RA, Case AH, Makani SS, Shepherd RW, Chen B, Holt GE, Martel S. Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2019 Dec 1;200(11):1354-1362. doi: 10.1164/rccm.201902-0383OC.
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Evaluation of the Spiration® Valve System for Emphysema to Improve Lung Function

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