Evaluation of the Spiration Valve for Emphysema to Improve Lung Function

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Jacksonville, Florida: 13-002690
    NCT ID: NCT01812447
    Sponsor Protocol Number: CPR-03434

About this study

This is a multicenter, prospective, randomized, controlled study designed to evaluate improvement of lung function after treatment with the Spiration Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group.

The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Subject has severe and heterogeneous emphysema with severe dyspnea
  • Subject certified to meet the criteria of ATS/ERS guidelines for management of stable COPD
  • Subject must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of ≥ 140 m
  • Subject has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study
  • Pulmonary Function Testing Results (PFT's) demonstrate
    • FEV1 ≤ 45% of predicted
    • RV ≥ 150% of predicted
    • TLC ≥ 100% of predicted

 

Exclusion Criteria

  • Patient has a BMI < 15 kg/m2 or > 35 kg/m2
  • Arterial Blood Gas Level (ABG) indicates
    • PCO2 > 50 mm Hg
    • PO2 < 45 mm Hg on room air
  • Subject has a diffuse emphysema pattern or α1-antitrypsin deficiency
  • Subject has bronchitis with sputum production > 4 Tablespoons or 60 ml per day
  • Subject has an active asthma (>15 mg of prednisone daily)
  • Giant bulla (> 1/3 volume of lung)
  • Pulmonary hypertension
  • Subject with prior major lung surgery or recent hospitalization for COPD exacerbation or respiratory infection

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Jorge Mallea, M.D.

Closed for enrollment

Contact information:

Verna Skinner CCRP

(904)953-2255

Skinner.Verna@mayo.edu

More information

Study Progress

This study has completed enrollment of targeted participants and currently is completing research activities including study intervention, specimen collection, testing and data analysis.

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20152251

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