Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

NCT01041586 | Completed Phase 1 DMC

• 1 other identifier: VAPOR-US
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Emphysema; Chronic Obstructive Pulmonary Disease

Keywords

Emphysema; COPD; Lung Volume Reduction; BTVA

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (1)

BTVA

EXPERIMENTAL

Device: BTVA System

Interventions

BTVA System DEVICE

Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction

BTVA

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uptake Medical Corp: lead

Study Sites (4)

John C. Lincoln Hospital

Phoenix, Arizona, United States

Location

University of Iowa

Iowa City, Iowa, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Swedish Hospital

Seattle, Washington, United States

Location

Related Publications (2)

• Herth FJ, Ernst A, Baker KM, Egan JJ, Gotfried MH, Hopkins P, Stanzel F, Valipour A, Wagner M, Witt C, Kesten S, Snell G. Characterization of outcomes 1 year after endoscopic thermal vapor ablation for patients with heterogeneous emphysema. Int J Chron Obstruct Pulmon Dis. 2012;7:397-405. doi: 10.2147/COPD.S31082. Epub 2012 Jul 18.

  PMID: 22927751 DERIVED

• Snell G, Herth FJ, Hopkins P, Baker KM, Witt C, Gotfried MH, Valipour A, Wagner M, Stanzel F, Egan JJ, Kesten S, Ernst A. Bronchoscopic thermal vapour ablation therapy in the management of heterogeneous emphysema. Eur Respir J. 2012 Jun;39(6):1326-33. doi: 10.1183/09031936.00092411. Epub 2011 Nov 10.

  PMID: 22075481 DERIVED

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 31, 2009
• Study Start: December 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 23, 2012

Record last verified: 2012-02

Locations

US (4)