Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study


  • Study type

  • Study phase

  • 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.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 12-007321
    NCT ID: NCT01608490
    Sponsor Protocol Number: CLN0009

About this study

Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System

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 is greater than or equal to 35 yrs of age
  • CT Scan indicates bilateral emphysema
  • Subject has post-bronchodilator FEV1 less than or equal to 45% predicted
  • Subject has Total Lung Capacity >100% predicted
  • Subject has residual volume (RV) greater than or equal to 175% predicted
  • Subject has marked dyspnea greater than or equal to 2 on mMRC scale of 0-4
  • Subject has stopped smoking for at least 8 weeks prior to entering the study as confirmed by a Cotinine test or other appropriate diagnostic test.
  • Subject has completed a pulmonary rehabilitation program within 6 mos prior to treatment and/or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 6 mos prior to baseline testing.
  • Subject has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy.
  • Subject (and legal guardian, if applicable) has read, understood, and signed the Informed Consent form.

Exclusion Criteria:

  • Subject has severe homogeneous emphysema determined by Core Radiology Lab.
  • Subject has co-morbidities that may significantly reduce subject's ability to improve exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea.
  • Subject has a change in FEV1 of greater than 20% (or, for subjects with pre-bronchodilator FEV1 below 1L, a change of greater than 200mL) post-bronchodilator unless investigator can confirm by other means that subject does not have asthma.
  • Subject has DLCO of less than 20% of predicted.
  • Subject has severe gas exchange abnormalities, PaCO2 of greater than 55mm Hg; PaO2 of less than 45 mm Hg on room air (high altitude criterion: PaO2 of less than 30mm Hg).
  • Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment.
  • Subject as severe pulmonary hypertension defined by right ventricular systolic pressure of greater than 50mm Hg and/or echocardiogram
  • Subject has an inability to walk >140m (150 yd) in 6 minutes
  • Subject has evidence of other severe disease (such as but not limited to lung cancer or renal failure), which in the judgment of the investigator may compromise survival of the subject for the duration of the study.
  • Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
  • Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia.
  • Subject has clinically significant bronchiectasis.
  • Subject has giant bullae >1/3 lung volume
  • Subject has had previous LVR surgery, lung transplantation, lobectomy or LVR devices in either lung.
  • Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
  • Subject is taking >20mg prednisone (or equivalent dose of a similar steroid) daily.
  • Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.
  • Subject is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as Heparin or Coumadin) which cannot be stopped for 7 days prior to the procedure.
  • Subject has any other disease, condition(s) or habit(s) that would interfere with completion of study and follow up assessments, would increase risks of bronchoscopy or assessments, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.
  • Subject has a sensitivity or allergy to Nickel.
  • Subject has a known sensitivity to drugs required to perform bronchoscopy.
  • Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

James Utz, M.D.

Closed for enrollment

Contact information:

Pulmonary Clinical Research Unit

(800) 753-1606


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