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| ID | Type | Description | Link |
|---|---|---|---|
| CVI-12-03-005102 | Other Identifier | Eudamed Number |
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Targeted Lung Denervation (TLD) Therapy will be a safe method to ablate the airway nerve trunks that travel parallel to and outside of the main bronchi and into the lungs to achieve targeted lung denervation and potentially improve breathing and quality of life for patients suffering from COPD.
Use of the IPS System will be technically feasible in accessing the target treatment location and delivering RF energy to the target treatment location.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Targeted Lung Denervation Therapy (TLD Therapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPS System | Device | TLD Therapy will be achieved bronchoscopically. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint | Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure. | 365 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Performance | Performance will be evaluated as the ability of the IPS System to access the target treatment area and deliver RF energy to the target treatment site at the time of the procedure, as well as confirmation of clinical evidence of successful lung denervation. | 365 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arschang Valipour, MD, FCCP, Ass. Prof. | Otto-Wagner Hospital, Vienna, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otto-Wagner Hospital and Medical Center | Sanatoriumstrasse 2 | State of Vienna | 1140 | Austria | ||
| Centre Hospitalier et Universitaire de Grenoble |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Grenoble |
| France |
| Centre Hospitalier University de Reims | Reims | France |
| Nouvel Hopital Civil | Strasbourg | France |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |