Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

Uptake Medical

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease; Emphysema

Treatments: Device: BTVA System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01102712

Vapor-OUS

Details and patient eligibility

About

To establish and confirm the safety and clinical utility of BTVA applied unilaterally for lung volume reduction in patients with upper lobe predominate heterogeneous severe emphysema.

Full description

All subjects meeting the eligibility criteria and who provide written informed consent will be enrolled. Up to 3 segments in either the right or left upper lobe will be treated with a vapor dose of 10 calories per gram of lung tissue (10 cal/g). Targeted lobe for treatment will be based on lobar disease severity.

Enrollment: 34 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age: > 40 and ≤ 75 years old
2. Diagnosis of heterogeneous emphysema with upper lobe predominance
3. FEV1 < 45% predicted
4. TLC > 100% predicted
5. RV > 150% predicted
6. 6-minute walk test > 140 meters
7. mMRC ≥ 2 (mMRC)
8. Non-smoking for 3 months
9. Optimized medical management and completed pulmonary rehabilitation

Exclusion criteria

1. Known α-1-antitrypsin deficiency
2. BMI < 15 kg/m2 or > 35 kg / m2
3. History of pneumothorax within previous 18 months
4. History of heart and / or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, and/or lobectomy
5. Respiratory infections or recurring COPD exacerbations > 3 hospitalizations in past 12 months or active infection
6. History of the (EF) ≤ 40%; Stroke; Unstable Myocardial Ischemia; FEV1 < 15% predicted; DLCO < 20% predicted; pulmonary hypertension; indwelling pacemaker or implantable cardiac defibrillator (ICD); pregnancy or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

BTVA

Experimental group

Treatment:

Device: BTVA System