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Changes in Lung Physiology and Cardiac Performance in Patients With Emphysema Post Bilateral RePneu Coil Treatment

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ClinicalTrials.gov Identifier: NCT02499380
Recruitment Status : Unknown
Verified April 2016 by PneumRx, Inc..
Recruitment status was:  Recruiting
First Posted : July 16, 2015
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
PneumRx, Inc.

Brief Summary:
The objective of this post-marketing study is to advance the understanding of the mechanism of action of the CE marked RePneu Coil by observing changes in lung physiology and cardiac performance in patients with emphysema treated with the RePneu Coils, when used as intended.

Condition or disease Intervention/treatment
Emphysema Device: PneumRx Coil System

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Lung Physiology and Cardiac Performance in Patients With Emphysema Post Bilateral RePneu Coil Treatment
Study Start Date : June 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Group/Cohort Intervention/treatment
Treatment
Patients treated with PneumRx Coil System
Device: PneumRx Coil System
Other Names:
  • LVRC
  • RePneu




Primary Outcome Measures :
  1. Changes in 6 Minute Walk Distance (6MWD) [ Time Frame: 3 and 12 months post final treatment ]

Secondary Outcome Measures :
  1. Changes in Lung Volumes [ Time Frame: 3 and 12 months post final treatment ]
  2. Changes in SGRQ [ Time Frame: 3 and 12 months post final treatment ]
  3. Changes in mMRC [ Time Frame: 3 and 12 months post final treatment ]
  4. Changes on Heart Echo [ Time Frame: 3 and 12 months post final treatment ]
  5. Changes in Lung Compliance [ Time Frame: 3 and 12 months post final treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult subjects diagnosed with emphysematous type of COPD
Criteria

Inclusion Criteria:

  1. Adult subjects diagnosed with emphysematous type of COPD.
  2. CT scan indicates bilateral emphysema, with sufficient lung parenchyma for coil deployment (based on PneumRx CT scoring) criteria.
  3. Subject has post-bronchodilator FEV1 ≤45% predicted.
  4. Subject has Total Lung Capacity >100% predicted.
  5. Subject has residual volume (RV) ≥175% predicted.
  6. Subject has marked dyspnea scoring ≥2 on mMRC scale of 0-4.
  7. Subject read, understood and signed the Informed Consent form.
  8. Subject has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy.

Exclusion Criteria:

  1. 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 not due to dyspnea.
  2. Subject has a change in FEV1 >20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of > 200 mL) post-bronchodilator unless investigator can confirm by other means that subject does not have asthma.
  3. Subject has severe gas exchange abnormalities as defined by:

    • PaCO2 >55 mm Hg
    • PaO2 <45 mm Hg on room air (High altitude criterion: PaO2 <30 mm Hg)
  4. Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >50 mm Hg via right heart catheterization and/or echocardiogram.
  5. 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.
  6. Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
  7. Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia.
  8. Subject has clinically significant bronchiectasis.
  9. Subject has had previous LVR surgery, lung transplantation, lobectomy or other BLVR treatment in either lung.
  10. Subject has participated in studies to treat COPD using high dose radiation.
  11. Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
  12. Subject is chronically taking >20 mg prednisone (or equivalent dose of a similar steroid) daily.
  13. Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.
  14. Subject is on any type of antiplatelet or anticoagulant therapy which cannot be stopped for seven (7) days prior to procedure.
  15. Subject has a sensitivity or allergy to Nickel.
  16. Subject has a known sensitivity to drugs required to perform bronchoscopy.
  17. Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD).
  18. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499380


Contacts
Contact: Jozef Tanczos +41795154691 jozef@pneumrx.com

Locations
Germany
Lungenclinic Recruiting
Grosshansdorf, Germany
Thoraxklinik Recruiting
Heidelberg, Germany
Sponsors and Collaborators
PneumRx, Inc.

Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT02499380     History of Changes
Other Study ID Numbers: CLN0017
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016

Keywords provided by PneumRx, Inc.:
RePneu
Coil
LVRC
PneumRx

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases