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

Study ID
CPR-03434

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Clements University Hospital

Contact
Adetoun Sodimu
214/645-6493
adetoun.sodimu@utsouthwestern.edu

Principal Investigator
Muhanned Abu-Hijleh, M.D.

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

Brief Overview


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.

Summary


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

Participant 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