A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Heterogeneous Emphysema.

Completed

Conditions: COPD emphysema
10038716

Registration Number: NL-OMON43476

Lead Sponsor: Pulmonx International Sarl

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

1. Obtained informed consent.
2. Diagnosis of heterogeneous emphysema with a heterogeneity index of >=10 % between
target and adjacent lobes.
3. Subjects of both genders of at least 40 years of age.
4. 15 % predicted <= FEV1<= 45% predicted.
5. TLC > 100% and RV >= 180% predicted.
6. 150 meters < 6MWT < 450 meters.
7. Non-smoker >8 weeks prior to signing the Informed Consent.
8. CV negative target lobe.

Exclusion Criteria

1. Any contraindication for bronchoscopic procedure.
2. Evidence of active pulmonary infection.
3. History of 2 or more exacerbations requiring hospitalization over the past 12 months.
4. Known Pulmonary hypertension that according to the physician will be unsuitable for
EBV treatment.
5. Myocardial infarction or other relevant cardiovascular events in the past 6 months.
6. Significant bronchiectasis seen at CT scan.
7. Greater than two tablespoons of sputum production per day.
8. Prior LVR or LVRS procedure.
9. Pulmonary nodule requiring follow-up within any lobe.
10. Pregnant or nursing women.
11. Hypercapnia (paCO2 > 7.33 kPa).
12. Current diagnosis of asthma.
13. > 25mg Prednisolon (or equivalent) use/days.
14. Any other condition that as judged by the investigator may make follow-up or
investigations inappropriate.
15. Evidence of pleural adhesions or earlier pulmonary surgery.
16. Severe Bulleous Emphysema (> 1/3 Hemithorax)
17. Any subject that according to the Declaration of Helsinki is unsuitable for enrollment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The percentage of Trial participants in the EBV treatment arm meeting the<br /><br>minimally clinically important difference (MCID) of >12% improved forced<br /><br>expiratory volume in one second (FEV1), obtained immediately following<br /><br>bronchodilator therapy, as compared to the percentage in the control<br /><br>arm at 3 months post-procedure.</p><br>

Secondary Outcome Measures