NL-OMON43476已完成不适用
A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Heterogeneous Emphysema. - TRANSFORM
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
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. Obtained informed consent.
- •2. Diagnosis of heterogeneous emphysema with a heterogeneity index of >=10 % between
- •target and adjacent lobes.
- •3. Subjects of both genders of at least 40 years of age.
- •4. 15 % predicted <= FEV1<= 45% predicted.
- •5. TLC > 100% and RV >= 180% predicted.
- •6. 150 meters < 6MWT < 450 meters.
- •7. Non-smoker >8 weeks prior to signing the Informed Consent.
- •8. CV negative target lobe.
排除标准
- •1. Any contraindication for bronchoscopic procedure.
- •2. Evidence of active pulmonary infection.
- •3. History of 2 or more exacerbations requiring hospitalization over the past 12 months.
- •4. Known Pulmonary hypertension that according to the physician will be unsuitable for
- •EBV treatment.
- •5. Myocardial infarction or other relevant cardiovascular events in the past 6 months.
- •6. Significant bronchiectasis seen at CT scan.
- •7. Greater than two tablespoons of sputum production per day.
- •8. Prior LVR or LVRS procedure.
- •9. Pulmonary nodule requiring follow-up within any lobe.
- •10. Pregnant or nursing women.
- •11. Hypercapnia (paCO2 > 7.33 kPa).
- •12. Current diagnosis of asthma.
- •13. > 25mg Prednisolon (or equivalent) use/days.
- •14. Any other condition that as judged by the investigator may make follow-up or
- •investigations inappropriate.
- •15. Evidence of pleural adhesions or earlier pulmonary surgery.
- •16. Severe Bulleous Emphysema (> 1/3 Hemithorax)
- •17. Any subject that according to the Declaration of Helsinki is unsuitable for enrollment.
研究者
相似试验
已完成
不适用
A Multi-center, Prospective, Randomized, Controlled Single Arm Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema.COPD emphysema10038716NL-OMON41236Pulmonx International Sarl25
进行中（未招募）
不适用
A Prospective, Multi-center, Randomized, Controlled Clinical Investigation of Dermagraft® in Subjects with Venous Leg Ulcers - Dermagraft® in Venous Leg Ulcers (DEVO)Venous leg ulcersMedDRA version: 9.1Level: LLTClassification code 10024134Term: Leg ulcer (exc varicose)EUCTR2009-010062-33-DEAdvanced BioHealing Inc442
进行中（未招募）
不适用
A Prospective, Multi-center, Randomized, Controlled Clinical Investigation of Dermagraft® in Subjects with Venous Leg Ulcers - Dermagraft® in Venous Leg Ulcers (DEVO)Venous leg ulcersMedDRA version: 9.1Level: LLTClassification code 10024134Term: Leg ulcer (exc varicose)EUCTR2009-010062-33-SEAdvanced BioHealing Inc442
进行中（未招募）
不适用
A Prospective, Multi-center, Randomized, Controlled Clinical Investigation of Dermagraft® in Subjects with Venous Leg Ulcers - Dermagraft® in Venous Leg Ulcers (DEVO)Venous leg ulcersMedDRA version: 9.1Level: LLTClassification code 10024134Term: Leg ulcer (exc varicose)EUCTR2009-010062-33-ATAdvanced BioHealing Inc442
进行中（未招募）
不适用
A Prospective, Multi-center, Randomized, Controlled Clinical Investigation of Dermagraft® in Subjects with Venous Leg Ulcers - Dermagraft® in Venous Leg Ulcers (DEVO)Venous leg ulcersMedDRA version: 9.1Level: LLTClassification code 10024134Term: Leg ulcer (exc varicose)EUCTR2009-010062-33-EEAdvanced BioHealing Inc442