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Bronchoscopic Lung Volume Reduction Device

Spiration Valve System for Emphysema (EMPROVE Trial)

N/A
Waitlist Available
Research Sponsored by Spiration, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 severe and heterogeneous emphysema with severe dyspnea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Awards & highlights

EMPROVE Trial Summary

This trial is designed to see if the Spiration Valve System is safe and effective in treating patients with emphysema who are still symptomatic despite medical treatment. α-1 antitrypsin deficiency patients are also being accepted.

Eligible Conditions
  • Emphysema

EMPROVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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The subject must be able to walk a distance of at least 140 meters in 6 minutes.
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at rest This person has a severe, heterogeneous case of emphysema that causes severe dyspnea even at rest.
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The subject has abstained from smoking cigarettes for four months and is willing to continue abstaining throughout the study.
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The patient's FEV1 is less than 45% of what is predicted for their sex, age, and height.
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This text means that the RV (respiratory volume) is 150% or more of what is predicted.

EMPROVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
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
+3 more
Other outcome measures
Incidence of thoracic SAEs

EMPROVE Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Spiration Valve System, α-1Experimental Treatment2 Interventions
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.
Group II: Spiration Valve SystemExperimental Treatment2 Interventions
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.
Group III: Medical ManagementActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spiration Valve System
2013
N/A
~290

Find a Location

Who is running the clinical trial?

Spiration, Inc.Lead Sponsor
11 Previous Clinical Trials
867 Total Patients Enrolled
6 Trials studying Emphysema
654 Patients Enrolled for Emphysema
Olympus Corporation of the AmericasLead Sponsor
20 Previous Clinical Trials
2,043 Total Patients Enrolled
6 Trials studying Emphysema
654 Patients Enrolled for Emphysema

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
Tennessee
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
UT Southwestern Medical Center at Dallas
~15 spots leftby Mar 2025