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EmphysemaPhase 2NCT00145548

Pilot Study of the Spiration IBV™ System

A Phase 2 study testing Intra Bronchial Valve in people with Emphysema, run by Olympus Corporation of the Americas at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Emphysema
What is being tested?
Intra Bronchial Valve
Type of treatment
Medical device
How many people
91 participants
Where
14 sitesUnited States
Study dates
Dec 2003to Aug 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.
  • Subject has willingness to participate in the study and complete the required follow-up visits.
  • Subject has ability to provide informed consent.
  • Subject has provided consent for treatment under this protocol and has granted access to relevant medical records to the sponsor, the Principal Investigator, the institution, the IRB and the FDA pertaining to their current lung disease condition, evaluation process, and the surgical procedure.

Who cannot join

  • 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.
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  • 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.
  • Subject has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
  • Subject has only the homogeneous emphysema pattern.
  • Subject is classified as ASA Class greater than P4 7 including presence of co-morbidity that could significantly increase the risk of a standard bronchoscopy procedure.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Emory Health Care

    Atlanta, Georgia, 30322

  • University of Alabama

    Birmingham, Alabama, 35294

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43210

  • Duke University Medical Center

    Durham, North Carolina, 27110

  • Indiana University

    Indianapolis, Indiana, 46202

  • North Shore - Long Island Jewish Health System

    Long Island City, New York, 11030

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Columbia University Medical Center

    New York, New York, 10032

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • University of Washington Medical Center

    Seattle, Washington, 98195

Other trials in United States

About this study

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.

Read the detailed description

This pilot study is an open enrollment, prospective study with each subject serving as their own control. The sponsor may attempt to include the data from this study in the statistical analysis of the pivotal study. This proposal shall be evaluated at the conclusion of the pilot study.

PATIENT POPULATION Patients with severe emphysema are eligible to be screened for enrollment in this study. In this initial pilot study, eligible subjects will have severe, heterogeneous, predominantly upper lobe emphysema, as defined by the American Thoracic Society (ATS) 1 and the NETT Research Group.2

These subjects also will be patients who have been screened as potential candidates for LVRS, but who have been excluded from surgical treatment due to a failure to satisfy the inclusion and exclusion criteria established by the NETT Research Group for LVRS.2 Patients also will be able to tolerate a flexible bronchoscopy procedure.

Patients who have been screened and accepted for a lung transplant procedure or LVRS, and are currently registered or scheduled for such a procedure, are not eligible for enrollment in this pilot study.

Patients with an FEV1 < 20% predicted and either homogeneous emphysema or DLCO < 20% will be excluded from enrollment in this pilot study.3

Patients will be screened and enrolled until up to 115 subjects have undergone treatment with the IBV System. Up to 15 clinical centers will be selected to enroll and treat subjects.

Conditions
Emphysema
Being tested
Intra Bronchial Valve
Keywords
COPD
Medical subject headings
Emphysema, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intra Bronchial ValveDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2005 (estimated)
  2. Study startDec 2003
  3. Primary completionAug 2007
  4. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00145548
Sponsor's protocol ID
CPR-0003
Status last verified
May 2007
First submitted
1 Sep 2005
Last updated
16 Jun 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18684848

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intra Bronchial Valve in people with Emphysema, run by Olympus Corporation of the Americas at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00145548, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2011; AzTrials last refreshed its copy on 31 Oct 2026.

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