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EmphysemaEMPROVENCT01812447

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

A study testing Spiration Valve System and Medical Management in people with Emphysema, run by Olympus Corporation of the Americas at 34 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Emphysema
What is being tested?
Spiration Valve System and Medical Management
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
34 sitesin 2 countries
Study dates
Jun 2013to Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

United States32 sites

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • University of Maryland

    Baltimore, Maryland, 21201

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Fletcher Allen Medical Center

    Burlington, Vermont, 05401

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • University of Chicago

    Chicago, Illinois, 60561

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Kaiser Permanente Northwest Medical Center

    Clackamas, Oregon, 97015

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75235

  • Beaumont Botsford Hospital (DCRC)

    Farmington Hills, Michigan, 48336

  • Sparks Regional Medical Center

    Fort Smith, Arkansas, 72901

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Michael DeBakey VA Medical Center

    Houston, Texas, 77030

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32216

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Miami VA Healthcare System

    Miami, Florida, 33125

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Cornell NYPH

    New York, New York, 10065

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Kaiser Permanente Riverside Medical Center

    Riverside, California, 92505

  • University of Utah

    Salt Lake City, Utah, 84132

  • University of California San Diego

    San Diego, California, 92103

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Louisiana State University Hospital

    Shreveport, Louisiana, 71130

  • Tampa General Hospital

    Tampa, Florida, 33606

Other trials in United States

Canada2 sites

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

  • Laval University

    Québec, Quebec, G1V 0A6

Other trials in Canada

About this study

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

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.

Read the 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.

  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

Conditions
Emphysema
Being tested
Spiration Valve System, Medical Management
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
Medical subject headings
Emphysema, Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema, Pathologic Processes, Lung Diseases, Respiratory Tract Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spiration Valve SystemDevice

    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.

  • Medical ManagementOther

    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.

Study groups in NCT01812447
Study groupRoleWhat they receive
Spiration Valve SystemExperimentalSubjects 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.
Receives: Device: Spiration Valve System; Other: Medical Management
Spiration Valve System, α-1Experimentalα-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.
Receives: Device: Spiration Valve System; Other: Medical Management
Medical ManagementActive comparatorThe 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.
Receives: Other: Medical Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline and 6 Months

Secondary outcomes (6)

  1. Target lobe volume reduction as measured by QCT

    Measured: Baseline and 6 Months

  2. Hyperinflation as measured by the ratio of Residual Volume to Total Lung Capacity (RV/TLC)

    Measured: Baseline and 6 Months

  3. Health Status as measured by St. George's Respiratory Questionnaire (SGRQ)

    Measured: Baseline and 6 Months

  4. Dyspnea as measured by Modified Medical Research Council Questionnaire (mMRC)

    Measured: Baseline and 6 Months

  5. Exercise capacity as measured by Six Minute Walk Test (6MWT)

    Measured: Baseline and 6 Months

  6. FEV1 Responders, defined as those achieving at least 15% improvement from baseline

    Measured: Baseline and 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionNov 2017
  4. Study completionAug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01812447
Sponsor's protocol ID
CPR-03434
Acronym
EMPROVE
Status last verified
May 2024
First submitted
7 Mar 2013
Last updated
31 May 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31365298

  • Hogarth DK, Delage A, Zgoda MA, Nsiah-Dosu S, Himes D, Reed MF. Efficacy and safety of the Spiration Valve System for the treatment of severe emphysema in patients with Alpha-1 antitrypsin deficiency (EMPROVE). Respir Med. 2024 Apr;224:107565. doi: 10.1016/j.rmed.2024.107565. Epub 2024 Feb 14.

    PubMed 38364975

  • Criner GJ, Mallea JM, Abu-Hijleh M, Sachdeva A, Kalhan R, Hergott CA, Lazarus DR, Mularski RA, Calero K, Reed MF, Nsiah-Dosu S, Himes D, Kubo H, Kinsey CM, Majid A, Hogarth DK, Kaplan PV, Case AH, Makani SS, Chen TM, Delage A, Zgoda M, Shepherd RW. Sustained Clinical Benefits of Spiration Valve System in Patients with Severe Emphysema: 24-Month Follow-Up of EMPROVE. Ann Am Thorac Soc. 2024 Feb;21(2):251-260. doi: 10.1513/AnnalsATS.202306-520OC.

    PubMed 37948704

Questions about this trial

What is this clinical trial studying?

A study testing Spiration Valve System and Medical Management in people with Emphysema, run by Olympus Corporation of the Americas at 34 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01812447, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.

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