Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

Uptake Medical Corp10 enrolled

Overview

To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous upper lobe emphysema.

All subjects meeting the eligibility criteria and who provide written informed consent will be enrolled. Immediately prior to BTVA treatment, an initial bronchoscopy will be performed to evaluate the baseline condition of the airways and to confirm anatomy of the lung segments targeted for BTVA treatment. 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Emphysema Chronic Obstructive Pulmonary Disease

Interventions

BTVA SystemDEVICE

Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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; of pulmonary hypertension; indwelling pacemaker or implantable cardiac defibrillator (ICD); pregnancy or breastfeeding

Locations (4)

John C. Lincoln Hospital

Phoenix, Arizona, United States

University of Iowa

Iowa City, Iowa, United States

Unnamed facility

Boston, Massachusetts, United States

Swedish Hospital

Seattle, Washington, United States

Outcomes

Primary Outcomes

Occurence of adverse events (serious and non-serious) secondary to the BTVA treatment procedure from initiation of treatment through completion of the six-month follow-up period

Time frame: 6 months

Secondary Outcomes

Radiographic evidence of lung volume reduction (assessed by study site radiologist) and CT scan (assessed by blinded radiologist at CT core lab)

Time frame: 6 months

Data from ClinicalTrials.gov

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