A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD

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Description

A total of 270 patients will be randomized at up to 40 United States study centers and up to 10 centers outside the US (Canada and Europe). A maximum of 90 patients (33% of the total study population) will be randomized outside the United States. A maximum of 40 patients (15% of the total study population) may be randomized at a single study center.

Details
Age

Adult

Eligibility

Criteria Inclusion Criteria: Patient is at least 35 years of age. Patient has chronic bronchitis, defined as productive cough for three months in each of two successive years, whereas other causes of productive cough have been ruled out. Patient has a CAT score ≥ 10. Patient has an SGRQ score ≥ 25. Patient's responses to the first two questions of the CAT instrument sum to ≥ 7 points or the sum is 6 points and the patient's total CAT score is > 20 points. Patient has FEV1/FVC < 0.7. Patient has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥ 30%. Patient is receiving guideline directed pharmacotherapy which includes one or more long acting bronchodilator (LAMA, LABA) with or without an inhaled corticosteroid for at least 8 weeks prior to randomization Patient has a cigarette smoking history of at least ten pack years. In the opinion of the Primary investigator, patient is able to undergo 2 bronchoscopies under general anesthesia and is able to adhere to the study follow-up schedule Exclusion Criteria: Patient has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis). Patient has a steroid-dependent condition requiring >10 mg of oral corticosteroid per day. Patient has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator, neuro-stimulation devices). Patient has a history of arrhythmia within past two years which includes tachy-atrial arrhythmias, any ventricular tachy-arrhythmias, or sinus bradycardia with heart rate less than 45 beats per minute. Patient has unresolved lung cancer. Patient has a pulmonary nodule or cavity that in the judgement of the Primary investigator may require intervention during the course of the study. Patient had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy. Prior pneumothorax without lung resection, pleural procedures without surgery, or segmentectomy are acceptable. Patient has emphysema of greater than or equal to 20% as quantified on baseline HRCT scan (low attenuation area less than -950HU) as determined by the CT Core Lab. Patient has asthma based on Global Initiative for Asthma (GINA) criteria. Patient has clinically significant bronchiectasis influencing the patient's clinical symptoms of cough and phlegm. Patient has actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months. Patient is unable to walk over 225 meters in 6 minutes. Patient has a serious medical condition that, in the Primary investigator's opinion, could compromise patient safety or confound the interpretation of the patient's response to therapy (e.g., congestive heart failure, cardiomyopathy, or myocardial infarction in the past year, renal failure, liver disease cerebrovascular accident within the past 6 months, uncontrolled diabetes (HbA1c >8%), uncontrolled hypertension (diastolic BP >100mmHg) or autoimmune disease requiring treatment with immunosuppressant medications or a disease requiring chemotherapy). Patient has uncontrolled GERD. Patient has known severe pulmonary hypertension. Patient has a known sensitivity to medication required to perform bronchoscopy (i.e., lidocaine, atropine, benzodiazepines). Patient is pregnant, nursing, or planning to get pregnant during study duration. Patient is currently participating in another clinical study involving an investigational product

Type of Study

Device Feasibility

Locations

University of Colorado Hospital

Principal Investigator
Photograph of Ali Musani,  MD

Ali Musani, MD

Study ID

Protocol Number: 21-4436

More information available at ClinicalTrials.gov: NCT04677465

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