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The purpose of this study is to evaluate the safety of Targeted Lung Denervation Therapy (or TLD TherapyTM) in patients suffering from COPD. Technical feasibility of the IPS SystemTM will also be evaluated through confirmation of successful application of TLD Therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted Lung Denervation | Experimental | Targeted Lung Denervation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLD Therapy (IPS SystemTM) | Device | Targeted Lung Denervation Therapy will be achieved bronchoscopically. As this is a single-arm, non-randomized study, it is anticipated that all patients who provide written informed consent and meet the protocol entry criteria will undergo treatment. |
| 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 post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Feasibility | The ability to access the target treatment area and deliver RF energy to the target treatment site. | At time of Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dirk-Jan Slebos, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen (UMCG) | Groningen | 9700 | Netherlands | |||
| Panorama Medi-Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25739911 | Result | Slebos DJ, Klooster K, Koegelenberg CF, Theron J, Styen D, Valipour A, Mayse M, Bolliger CT. Targeted lung denervation for moderate to severe COPD: a pilot study. Thorax. 2015 May;70(5):411-9. doi: 10.1136/thoraxjnl-2014-206146. Epub 2015 Mar 4. |
| Label | URL |
|---|---|
| Targeted lung denervation for moderate to severe COPD: a pilot study. | View source |
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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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|
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| Panorama |
| Cape Town |
| South Africa |
| Stellenbosch University | Capetown | 7505 | South Africa |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |