Emphysema
Conditions
Keywords
RePneu, Coil, LVRC, PneumRx
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.
Interventions
DEVICEPneumRx Coil System
Sponsors
PneumRx, Inc.
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in 6 Minute Walk Distance (6MWD) | Baseline, 12 months post initial treatment | Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 12 months after the initial treatment of the RePneu coil. 6MWD was measured in meters. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Patients treated with PneumRx Coil System
PneumRx Coil System | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 66.50 years STANDARD_DEVIATION 5.15 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 16 / 20 |
| serious Total, serious adverse events | 10 / 20 |
Outcome results
Primary
Changes in 6 Minute Walk Distance (6MWD)
Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 12 months after the initial treatment of the RePneu coil. 6MWD was measured in meters.
Time frame: Baseline, 12 months post initial treatment
Population: Intention to treat population with 6MWT data available at baseline and 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Changes in 6 Minute Walk Distance (6MWD) | 19.1 meters | Standard Deviation 63.06 |
Primary
Changes in 6 Minute Walk Distance (6MWD)
Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 3 months after final treatment of the RePneu coil. 6MWD was measured in meters.
Time frame: Baseline, 3 months post final treatment
Population: Intention to treat population with 6MWT data available at baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Changes in 6 Minute Walk Distance (6MWD) | 21.4 meters | Standard Deviation 46.94 |