A Prospective, Randomized, Placebo-Controlled Multicenter Study to Evaluate the Performance of the IBV Valve System for the Treatment of Severe Emphysema

Withdrawn

• Conditions: severe emphysema; 10006436

• Registration Number: NL-OMON30950
• Lead Sponsor: Spiration Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Subject is between 40 and 74 years of age.
Subject has predominantly upper lobe, emphysema and severe dyspnea.

Exclusion Criteria

Subjects with FEV1 and DLCO < 20% of predicted.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The study outcome will be the difference between the response rates of the<br /><br>treatment and control groups in disease-related health status as measured by<br /><br>the St. George*s Respiratory Questionnaire (SGRQ) total score and lung volume<br /><br>change as measured by CT scan at 3 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>No secundary study parameters. </p><br>