Pilot Study of the Spiration IBV™ System

NCT00145548 | Completed Phase 2 DMC

• 1 other identifier: CPR-0003
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 14

Brief Summary

The Spiration Intra-Bronchial Valve is intended for use as a minimally invasive treatment for severe emphysema, using standard bronchoscopy. The valve is designed to limit airflow to a selected portion of the lung, producing a reduction in lung volume, which may improve pulmonary function in patients with emphysema.

Conditions

Emphysema

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of this study is to evaluate the safety of the device, during deployment and short-term implantation for a period of up to 3 months.

Secondary Outcomes (1)

• The secondary endpoint is to estimate the effectiveness achieved after 1 and 3 months of use.

Interventions

Intra Bronchial Valve DEVICE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female subjects at least 18 years of age.
• Subject has severe, heterogeneous, predominantly upper lobe emphysema.
• Subject has ability to meet goals of, or currently satisfies goals of, a comprehensive pulmonary rehabilitation program.
• Subject has satisfied requirement for post-rehabilitation 6-minute walk of ≥ 140 m 6 and is able to complete 3 min unloaded pedaling in exercise tolerance test.
• Subject has abstained from cigarette smoking for 4 months, as confirmed by urine or serum cotinine test.
• Pulmonary function testing results demonstrate:
• FEV1 ≤ 45% predicted (≥ 15% predicted if age ≥ 70 years)
• TLC ≥ 100% predicted
• RV ≥ 150% predicted
• Arterial blood gas level indicates:
• PCO2 ≤ 50 mm Hg
• PO2 ≥ 45 mm Hg on room air (Denver criterion: PO2 ≥ 30 mm Hg)
• Subject has no co-existing major medical problems that would significantly increase the risk of the bronchoscopy procedure and is classified as ASA Class P4 or lower.
• If female, subject is not pregnant by a negative HCG pregnancy test within 7 days prior to the procedure.
• Subject has willingness to undertake the risk and morbidity associated with the required bronchoscopic procedures.

You may not qualify if:

• Patients with FEV1\< 20% predicted and either homogeneous emphysema or DLCO \< 20%. 3
• Subject is unable to provide informed consent.
• Subject is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures.
• Subject has dysrhythmia that might pose a risk during exercise or training.
• Subject has resting bradycardia (\< 50 beats/min); frequent multifocal PVCs; complex ventricular arrhythmia; sustained SVT.
• Subject has history of exercise-related syncope.
• Subject has uncontrolled hypertension (systolic, \> 200 mm; diastolic \> 110 mm).
• Subject has history of recurrent infections with clinically significant sputum production
• Subject has known, active asthma, chronic bronchitis or clinically significant bronchiectasis.
• Subject has giant bulla (\> 1/3 volume of lung).
• Subject has pulmonary hypertension: peak systolic PPA, ≥ 45 mm Hg (Denver criterion: ≥ 50 mm Hg) or mean PPA, ≥ 35 mm Hg (Denver criterion: ≥ 38 mm Hg). (Right heart catheter is required to rule out pulmonary hypertension if peak systolic PPA on echocardiogram is ≥ 45 mm Hg.)
• Subject has requirement for \> 6 L O2 to keep saturation ≥ 90% with exercise.
• Subject has evidence of systemic disease or neoplasia expected to compromise survival during the 1-year study period.
• Subject demonstrates 6MWT distance ≤ 140 m after rehabilitation.
• Subject has any disease or condition that interferes with completion of initial or follow-up assessments.

Sponsors & Collaborators

• Olympus Corporation of the Americas: lead

Study Sites (14)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Emory Health Care

Atlanta, Georgia, 30322, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

North Shore - Long Island Jewish Health System

Long Island City, New York, 11030, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27110, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Coxson HO, Nasute Fauerbach PV, Storness-Bliss C, Muller NL, Cogswell S, Dillard DH, Finger CL, Springmeyer SC. Computed tomography assessment of lung volume changes after bronchial valve treatment. Eur Respir J. 2008 Dec;32(6):1443-50. doi: 10.1183/09031936.00056008. Epub 2008 Aug 6.

  PMID: 18684848 DERIVED

Related Links

• Related Info

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 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: December 1, 2003
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: June 16, 2011

Record last verified: 2007-05

Locations

US (14)