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

NCT ID: NCT02499380

Last Updated: 2021-07-19

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-09
• Study Completion Date: 2018-10-20

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.

Conditions

Emphysema

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment

Patients treated with PneumRx Coil System

PneumRx Coil System

Intervention Type: DEVICE

Interventions

PneumRx Coil System

Intervention Type: DEVICE

Other Intervention Names

LVRC; RePneu

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PneumRx, Inc.

INDUSTRY

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lungenclinic

Großhansdorf, , Germany

Thoraxklinik

Heidelberg, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CLN0017

Identifier Type: -

Identifier Source: org_study_id