A Multi-center, Prospective, Randomized, Controlled Single Arm Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema.

Completed

• Conditions: 10038716; COPD emphysema

• Registration Number: NL-OMON41236
• Lead Sponsor: Pulmonx International Sarl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

1. Diagnosis of homogeneous emphysema with a heterogeneity index of < 15% between target and adjacent lobes
2. Subjects of both genders of at least 40 years of age
3. Understand and voluntarily sign a patient informed consent form
4. Diagnosis of COPD with a 15 % predicted <= FEV1<= 45% predicted despite optimal medical management
5. TLC > 100% predicted, RV >= 200% predicted
6. 6MWT >=150 meters
7. Non-smoker >8weeks prior to signing the Informed Consent
8. CV negative target lobe

Exclusion Criteria

1. Evidence of active pulmonary infection
2. History of more than 3 exacerbations with hospitalizations over the past 12 months
3. Evidence of pulmonary hypertension (sPAP > 45mmHg)
4. Myocardial infarction or other relevant cardiovascular events in the past 6 months
5. Evidence of Alpha 1 antitrypsin deficiency
6. Evidence of severe bronchiectasis with greater than two tablespoons of sputum production per day
7. Prior LVR or LVRS procedure
8. Pulmonary nodule requiring follow-up within the target lobe
9. > 20% difference in perfusion between left and right lung
10. Pregnant or nursing women
11. Hypercapnia (paCO2 > 55mmHg)
12. Asthma
13. > 25mg Aprednislon (or equivalent) use/days
14. Systemic or malignant disease with high probability of mortality within 12 months
15. Severe bullous emphysema

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage mean change in FEV1 at 3 months relative to baseline in the EBV<br /><br>group, compared to the Standard of Care (SoC) group.</p><br>