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Study enrollment was prematurely stopped for business reasons.
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| Name | Class |
|---|---|
| PneumRx, Inc. | INDUSTRY |
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The purpose of undertaking CLN0020, which was a Substudy of the European Coil registry (CLN0014), was to investigate the use of COPD Co-Pilot AIR™, a COPD disease management program manufactured and operated by HGE Health Care Solutions, LLC, in participants undergoing the PneumRx Endobronchial Coil Treatment in a post-market setting.
COPD Co-Pilot AIR™ combines a digital respiratory symptom reporting participant application (an "app") with facilitation of rapid personalized clinical recommendations made by the participant's health care provider and communicated to the participant through the application. COPD Co-Pilot AIR™ provides early identification of an increase in a participant's respiratory symptoms relative to the participant's own baseline symptom profile which in turn enables health care providers to rapidly implement modified treatment plans.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COPD Co-Pilot AIR App | Behavioral | App. For COPD symptoms after Coil procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of COPD Exacerbation | Rate of COPD Exacerbation serious adverse events (SAEs) reported in the 12-month period following the initial Endobronchial Coil procedure for participants enrolled in CLN0020 when compared to CLN0014 participant population that was not managed utilizing COPD Co-Pilot AIR. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Related SAEs | Percent of participants experiencing one or more respiratory-related SAEs in the 12-month period following the initial Coil procedure comparing participants enrolled in CLN0020 to non-COPD Co-Pilot AIR participants in CLN0014. | 12 months |
| Rate of First Respiratory-Related SAEs |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with COPD undergoing the PneumRx Endobronchial Coil Treatment in a post-market setting.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Franzen, MD | Klinik für Pneumologie, Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Genève (HUG) Service | Geneva | 1211 | Switzerland | |||
| UniversitätsSpital |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Rate of first respiratory-related SAEs reported in the 12-month period following the initial Coil procedure comparing participants enrolled in CLN0020 to non-COPD Co-Pilot AIR participants enrolled in CLN0014. |
| 12 months |
| Time to First Respiratory-Related SAE | Time to first respiratory-related SAE following the initial Coil procedure comparing participants enrolled in CLN0020 to non-COPD Co-Pilot AIR participants enrolled in CLN0014. | 12 months |
| Zurich |
| 8091 |
| Switzerland |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |