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This is a prospective, randomized, parallel group, double-blind, sham-controlled, multicenter clinical trial following patients to 2 years. The objective is to assess the safety and effectiveness of Bronchial Rheoplasty for the treatment of the symptoms of chronic bronchitis in adult COPD patients with moderate to severe chronic bronchitis. A total of 270 patients will be randomized at up to 40 study centers in the United States, Canada, and Europe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RheOx Treatment | Experimental |
| |
| Sham Procedure | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RheOx Bronchial Rheoplasty | Device | bronchial rheoplasty is a staged procedure wherein pulsed electric fields are delivered to the right lung in the first treatment visit, and then the left lung is treated approximately 1 month later. |
| Measure | Description | Time Frame |
|---|---|---|
| COPD Assessment Test (CAT) Score | Mean change from baseline in the COPD Assessment Test (CAT) total score, the total CAT score ranges from 0 to 40, where lower scores represent lower symptom burden | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Distal Airway Volume | Change from baseline distal airway volume (DAV) at expiration using HRCT scans | 6 months |
| COPD Exacerbations | Rate of moderate and severe COPD exacerbations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Sciurba, MD | UPMC; Division of Pulmonary and Critical Care Medicine | Principal Investigator |
| Arschang Valipour, MD | Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology; Vienna, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Norton Thoracic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39615802 | Derived | Krimsky WS, VanderLaan PA, Iding JS, Hunter DW, Hatton BA, Bannan B, Kim V. A quantitative method for assessing treatment-related changes within the airway mucosa in patients with chronic bronchitis. Respir Med. 2025 Jan;236:107889. doi: 10.1016/j.rmed.2024.107889. Epub 2024 Nov 28. |
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Parallel group design randomizing patients in a 2:1 ratio to the treatment vs. sham group. Randomization will be blocked and stratified by site and FEV1 (<50% vs. >/= 50%)
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| Sham Procedure | Device | staged sham procedure wherein bronchoscopy is performed, the catheter is inserted into the right lung, but energy is not delivered; then the same steps are performed in the left lung approximately 1 month later (no energy is delivered to the patient) |
|
| 12 months |
| Goblet Cell Hyperplasia | change from baseline in mean goblet cell hyperplasia score as determined from airway biopsy samples; the grading scale ranges from 0 to 3, where lower scores represent less goblet cell hyperplasia | 1 month |
| Cough Frequency | change from baseline in cough frequency (coughs/hour in a 24-hour recording period) | 6 and 12 months |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Honor Health | Scottsdale | Arizona | 85258 | United States |
| Syed M. Alam, MD Pulmonology (Bakersfield Heart) | Bakersfield | California | 93309 | United States |
| UC Davis Medical Center | Davis | California | 95817 | United States |
| Scripps Health | Encinitas | California | 92024 | United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| UCLA Harbor Lundquist Institute | Torrance | California | 90502 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| The Cardiac and Vascular Institute Research Foundation | Tallahassee | Florida | 32605 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| University of Kansas School of Medicine | Kansas City | Kansas | 66160 | United States |
| Tulane University Medical Center | New Orleans | Louisiana | 70112 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Minnesota Lung Center | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Mississippi | Jackson | Mississippi | 39216 | United States |
| Pinehurst Medical Clinic | Pinehurst | North Carolina | 28374 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| CHI Memorial Research Center | Chattanooga | Tennessee | 37404 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| JPS Health Network, Fort Worth | Fort Worth | Texas | 76104 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| Virginia Commonwealth University Health | Richmond | Virginia | 23298 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Klinik Floridsdorf - Abteilung für Innere Medizin und Pneumologie | Vienna | 1210 | Austria |
| Charité Universitätsmedizin Berlin, Campus Virchow Klinikum | Berlin | 13353 | Germany |
| Ruhrlandklinik Essen | Essen | 45239 | Germany |
| Thoraxklinik Heidelberg | Heidelberg | 69126 | Germany |
| ASST Spedali Civili Hospital | Brescia | 25123 | Italy |
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| ID | Term |
|---|---|
| D029481 | Bronchitis, Chronic |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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