NL-OMON51654已完成不适用
A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD - The RheSolve Study
GALA therapeutics0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patient is at least 35 years of age.
- •2. 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.
- •3. Patient has a CAT score >= 10.
- •4. Patient has an SGRQ score >= 25.
- •5. 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
- •6. Patient has FEV1/FVC < 0.7.
- •7. Patient has a pre-procedure post-bronchodilator FEV1 percent predicted of >=
- •8. 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
- •9. Patient has a cigarette smoking history of at least ten pack years.
- •10. 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.
- •11. Patient has provided informed consent.
排除标准
- •1. Patient has known unresolved lower respiratory tract infection (e.g.,
- •pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus,
- •tuberculosis).
- •2. Patient has a steroid-dependent condition requiring >10 mg of oral
- •corticosteroid per day.
- •3. Patient has any implantable electronic device (e.g., pacemaker, cardioverter
- •defibrillator, neuro-stimulation devices).
- •4. 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.
- •5. Patient has unresolved lung cancer.
- •6. Patient has a pulmonary nodule or cavity that in the judgement of the
- •Primary investigator may require intervention during the course of the study.
- •7. 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.
- •8. 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.
- •9. Patient has asthma based on Global Initiative for Asthma (GINA) criteria.
- •10. Patient has clinically significant bronchiectasis influencing the patient*s
- •clinical symptoms of cough and phlegm.
- •11. Patient has actively smoked (including tobacco, marijuana, e-cigarettes,
- •vaping, etc.) within the last 6 months.
- •12. Patient is unable to walk over 225 meters in 6 minutes.
- •13. 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).
- •14. Patient has uncontrolled GERD.
- •15. Patient has known severe pulmonary hypertension.
- •16. Patient has a known sensitivity to medication required to perform
- •bronchoscopy (i.e., lidocaine, atropine, benzodiazepines).
- •17. Patient is pregnant, nursing, or planning to get pregnant during study
- •18. Patient is currently participating in another clinical study involving an
- •investigational product.
- •19. Patient is on anticoagulation for cardiovascular indications and, at the
- •discretion of the Primary investigator, is unable to have anticoagulants (i.e.,
- •Aspirin, Plavix, Coumadin) withheld for the bronchoscopy procedure per
- •institution*s standard of care.
- •20. Patient has known airway colonization with resistant organisms, such as
- •pseudomonas, methicillin-resistant Staphylococcus aureus (MRSA), Burkholderia
- •cepacia complex, Mycobacterium Tuberculosis (MTB), Mycobacterium abscessus
- •mucor or significant fungus.
- •21. Patient has had prior severe respiratory infection with SARS-CoV-2
- 另有 3 项未显示
研究者
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