US Pilot Safety and Feasibility Study of Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction in Patients With Heterogeneous Emphysema With Upper Lobe Predominance
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Uptake Medical Corp
- Enrollment
- 10
- Locations
- 4
- Primary Endpoint
- 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
Study Overview
Brief Summary
To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous upper lobe emphysema.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: > 40 and ≤ 75 years old
- •Diagnosis of heterogeneous emphysema with upper lobe predominance
- •FEV1 < 45% predicted
- •TLC > 100% predicted
- •RV > 150% predicted
- •6-minute walk test > 140 meters
- •mMRC ≥ 2 (mMRC)
- •Non-smoking for 3 months
- •Optimized medical management and completed pulmonary rehabilitation
Exclusion Criteria
- •Known α-1-antitrypsin deficiency
- •BMI < 15 kg/m2 or > 35 kg / m2
- •History of pneumothorax within previous 18 months
- •History of heart and / or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, and/or lobectomy
- •Respiratory infections or recurring COPD exacerbations > 3 hospitalizations in past 12 months or active infection
- •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
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)(6 months)