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Compares treatment options for Emphysema
Official title Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema
ClinicalTrials.gov ID: NCT04537182
What this study is testing
- What it's testing
- The investigators plan to perform a randomized controlled trial that compares bilateral lung volume reduction surgery (LVRS) with bronchoscopic lung volume reduction (BLVR) using endobronchial valves in terms of efficacy and patient safety.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 80
You may be able to join if
- Patients suffering from emphysema (all morphologies, uni- or bilateral distribution) potentially qualifying for both study procedures, LVRS or BLVR...
- Age ≥ 30 and ≤ 80 years
- Body Mass Index (BMI) ≥ 16, but ≤ 35 kg/m2
- Non-smoking for 3 months prior to screening interview
- Patient is able to understand and willing to sign a written informed consent document.
You likely can't join if
- FEV1 more than 50% predicted
- TLC less than 100 % predicted, RV less than 175% predicted, RV/TLC less than 58% predicted, and DLCO ≤ 20% predicted in homogeneous emphysema and...
- PaO2 ≤ 6.0 kPa (45mm Hg) at ambient air (only applicable for homogeneous morphology!)
- PaCO2 ≥ 6.6 kPa (50 mmHg) at ambient air (only applicable for homogeneous morphology!)
- Patients with incomplete interlobar fissures as revealed by quantitative computed tomography analysis with StratX® (fissure completeness ≤ 80%)
- Patients with collateral ventilation as evidenced by bronchoscopic Chartis® measurement (only performed if fissure completeness according to StratX®...
See the full eligibility criteria
- Patients suffering from emphysema (all morphologies, uni- or bilateral distribution) potentially qualifying for both study procedures, LVRS or BLVR (if possible, perfusion scintigraphy within \< 6 month of screening, CT...
- Age ≥ 30 and ≤ 80 years
- Body Mass Index (BMI) ≥ 16, but ≤ 35 kg/m2
- Non-smoking for 3 months prior to screening interview
- Patient is able to understand and willing to sign a written informed consent document.
- FEV1 more than 50% predicted
- TLC less than 100 % predicted, RV less than 175% predicted, RV/TLC less than 58% predicted, and DLCO ≤ 20% predicted in homogeneous emphysema and DLCO ≤ 15% in heterogeneous emphysema, respectively
- PaO2 ≤ 6.0 kPa (45mm Hg) at ambient air (only applicable for homogeneous morphology!)
- PaCO2 ≥ 6.6 kPa (50 mmHg) at ambient air (only applicable for homogeneous morphology!)
- Patients with incomplete interlobar fissures as revealed by quantitative computed tomography analysis with StratX® (fissure completeness ≤ 80%)
- Patients with collateral ventilation as evidenced by bronchoscopic Chartis® measurement (only performed if fissure completeness according to StratX® is \< 95%)
- 6-minute walking distance ≥ 470m
- More than two COPD exacerbation episodes requiring hospitalization in the last year
- More than two instances of pneumonia episodes in the last year
- Unplanned weight loss ≥ 10% within 90 days prior to enrollment
- Pulmonary hypertension as evidenced by Delta Psyst RV-RA \> 35 mmHg on recent echocardiography (within 3 months prior to screening) and confirmed by RHC (mPAP ≥ 35 mmHg) and signs of moderate to severe RV dysfunction.
- Evidence of left ventricular ejection fraction (LVEF) less than 45% on recent echocardiography (within 3 months prior to screening)
- History of exercise-related syncope
- Myocardial infarction or congestive heart failure within 6 months of screening
- Clinically significant arrhythmias that might put the patient at risk in regard to the interventions
- Prior LVR (any method), bullectomy, or lobectomy
- Clinically significant bronchiectasis with expectoration of ≥ 2 tablespoons/day.
- Pulmonary nodule requiring surgery
- Unable to safely discontinue anticoagulants or dual antiplatelet therapy for 7 days
- Patients with a life expectancy of less than one year
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
- Leuven, Belgium
- Copenhagen, Denmark
- Aarau, Canton of Aargau, Switzerland
- Lausanne, Canton of Vaud, Switzerland
- Zurich, Canton of Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria; Leuven, Belgium; Copenhagen, Denmark; Aarau, Canton of Aargau, Switzerland; Lausanne, Canton of Vaud, Switzerland; Zurich, Canton of Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.