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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 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 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.


Sponsor: Spiration, Inc.

Current Primary Outcome: 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 ]

Original Primary Outcome: Change in Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: Baseline and 6 Months ]

Current Secondary Outcome:

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


Original Secondary Outcome:

  • Health Status as measured by St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Baseline and 6 Months ]
  • Dyspnea as measured by Modified Medical Research Council Questionnaire (mMRC) [ Time Frame: Baseline and 6 Months ]
  • Exercise capacity as measured by Six Minute Walk Test (6MWT) [ Time Frame: Baseline and 6 Months ]


Information By: Spiration, Inc.

Dates:
Date Received: March 7, 2013
Date Started: June 2013
Date Completion:
Last Updated: April 24, 2017
Last Verified: April 2017