ACTRN12622001327774招募中未知
The REDUCE Study – Safety of the Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Severe Emphysema with hyperinflation – A First in Human Study (CSP-11121)
Morair Medtech LLC0 个研究点目标入组 30 人开始时间: 2022年10月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •General Inclusion Criteria
- •1. Age greater than or equal to 18 and less than or equal to 75years old
- •2. Post-bronchodilator FEV1 greater than or equal to 20% and less than or equal to 50% of predicted value
- •3. Post-bronchodilator total lung capacity TLC greater than or equal to 100% predicted
- •4. Post-bronchodilator residual volume (RV) greater than or equal to 175% predicted
- •5. 6MWD (Six Minute Walk Distance) greater than or equal to 150 meters
- •6. PaCO2 less than or equal to 50 mm Hg and PaO2 greater than 45 mm Hg on room air
- •7. Non-smoking for 3 months prior to study enrollment, as confirmed by;
- •Negative urine analysis or serum cotinine level of less than or equal to 10 ng/mL, or if using smoking cessation product(s) containing nicotine at screening, serum cotinine level less than or equal to 13.7 ng/ml
- •Negative carboxyhemoglobin (COHb) test (less than or equal to 2.5%)
- •8. Optimized medical management (consistent with GOLD guidelines)
- •9. Evidence of completed pulmonary rehabilitation:
- •greater than or equal to 6 weeks out-patient or greater than or equal to 3 weeks in-patient within 6 months of enrollment;
- •Patient has or continues to participate in regular physical activity beyond activities of daily living (e.g., a walking program) for greater than 6 weeks under the supervision / in the opinion of a health care professional within 6 months of enrollment
- •10. Patient must meet ONE of the following criteria for distance from treating hospital:
- •Lives within approximately 1 hour of the study hospital
- •If greater than 1 hour from study hospital, lives within approximately 1 hour of regional care is sufficient to handle an emergency pulmonary event in COPD patients with surgical suite
- •If greater than 1 hour from study hospital and there is not sufficient regional care, patient is willing to stay at local hotel or other accommodation through 5-days post-discharge
- •11.See Public Notes at end of form
- •12. Current pneumococcus and influenza vaccination (or documented clinical intolerance or documented patient refusal)
- •13. Cognitively and physically able to provide written informed consent
- •Radiological Inclusion Criteria
- •14. Severe emphysematous sub-segments eligible for ETLA treatment where the volume of targeted sub-segments must meet the minimum phase volume, with the total targeted volume allowing for two (2) ETLA procedures. Eligible sub-segments are defined as having greater than or equal to 25% destruction %-950 HU per Quantitative CT analysis with a heterogeneity index (HI) greater than 1.2.
- •Note: Chest CT analysis by QCT Core lab
排除标准
- •General Exclusion Criteria
- •1. DLCO less than 20% predicted
- •2. Clinical evidence of Pulmonary hypertension (mPAP greater than 20mm Hg) or RV estimated systolic pressure greater than 45 mmHg as determined by recent (within the previous 12 months) echocardiogram or history of cor pulmonale
- •3. Clinically significant sputum production (greater than 5 tbsp per day)
- •4. Greater than two (2) COPD exacerbations or pneumonia episodes requiring hospitalization in the last year.
- •5. History of active asthma
- •6. Alpha-1 antitrypsin deficiency
- •7. Daily systemic steroids greater than 12.5 mg prednisolone (or equivalent).
- •8. Prior lung volume reduction via endobronchial valves(s), coil(s), vapor and/or polymer.
- •Note: Patients whose valves have been removed greater than 3 months prior can be treated if baseline bronchoscopy reveals no airway obstruction or obvious tissue granulation and the reason for valve removal was not complications e.g., pneumonia, severe exacerbation, or pneumothorax.
- •9. Myocardial Infarction or heart failure exacerbation within 6 months of screening.
- •10. Diagnosis of systolic heart failure with LVEF less than 45% determined by recent echocardiogram (completed within 12 months prior to screening).
- •Note: Subjects with no CHF diagnosis do NOT require current echo.
- •11. History of bleeding disorders or enhanced predisposition to bleeding.
- •12. Unable to discontinue anti-coagulants or platelet inhibitors (non-ASA and ASA greater than 100mg daily) pre-procedure and for greater than 6 weeks post-procedure.
- •13. Body mass index (BMI) greater than 30 kg/m2 or less than 16 kg/m2
- •14. Immunosuppressive drugs, such as for the treatment of cancer, autoimmune disease, or prevention of tissue/organ rejection.
- •15. Pregnant, lactating, or women of childbearing potential that plan to become pregnant within the study duration
- •16. Active aspergillus infection, history of aspergillus colonization or cavitation(s).
- •17. Lung nodule not proven stable unless proven to have benign pathology**
- •18. Prior lung transplant, bullectomy or lobectomy**
- •19. Any disease or condition likely to limit survival to less than one year
- •20. Concomitant illnesses or medications that may pose a significant increased risk for complications following treatment with ETLA.
- •21. Currently enrolled in another trial studying an experimental treatment.
- •22. Any condition in the opinion of the Investigator that would interfere with completion of the study including study assessments and procedure including bronchoscopy.
- •Radiological Exclusion Criteria
- •23. Remaining lung tissue NOT targeted for ETLA treatment is too highly diseased, defined as %-950 HU greater than or equal to 50%, after both ETLA procedure treatment plans are finalized.
- •Note: Applies to both lungs, each individually assessed, regardless of whether lung is targeted for ETLA (unilateral or bilateral treatment).
- •Note: Chest CT analysis by QCT Core lab
- •24. Significant bronchiectasis*
- •25. Significant pulmonary fibrosis*
- •26. Large bulla (defined as greater than 1/3 volume of a lung)*
- •27. Paraseptal emphysema*
- •28. Radiology Eligibility Reviewer indicates patient is not ideal for the treatment*
- •* Assessed by Radiology Eligibility Reviewer
- •** Assessed by Radiology Eligibility Reviewer in addition to site radiology
- •Pre-procedural Exclusion Criteria
- •29. Evidence of active infection in the lungs at the time of procedure (ex: elevated temperature, increased WBC from baseline, purulent sputum, or o
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