The Safety and Feasibility of Re-treating Patients With Severe Emphysema With the RePneu LVRC System: a Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number and type of adverse effects as a measure of safety between baseline and 6 months follow up
研究概览
简要总结
Rationale:
The combined data from 3 studies outside the Unites States investigating the Lung Volume Reduction Coil system (RePneu LVRC) showed statistically significant improvements in pulmonary function, exercise capacity and quality of life at both 6-Months and 12-Months post treatment. 24 months post treatment the improved pulmonary function and exercise capacity are slightly decreasing. Retreating the patient with the LVR coil system in other parts of the lung could potentially lead to new improvements in lung function, dyspnea, exercise capacity and quality of life and may reduce the rate of decline.
Objective:
To investigate the safety and feasibility of re-treating patients with severe Chronic Obstructive Pulmonary Disease (COPD) with the RePneu LVRC system.
详细描述
Rationale:
The combined data from 3 studies outside the Unites States investigating the Lung Volume Reduction Coil system (RePneu LVRC) showed statistically significant improvements in pulmonary function, exercise capacity and quality of life at both 6-Months and 12-Months post treatment. 24 months post treatment the improved pulmonary function and exercise capacity are slightly decreasing. Retreating the patient with the LVR coil system in other parts of the lung could potentially lead to new improvements in lung function, dyspnea, exercise capacity and quality of life and may reduce the rate of decline.
Objective:
To investigate the safety and feasibility of re-treating patients with severe Chronic Obstructive Pulmonary Disease (COPD) with the RePneu LVRC system.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated with the RePneu LVRC system > 24 months ago.
- •Six months after the first bilateral treatment with the RePneu LVRC system the patient had a significant improvement above the established minimal important difference (MID) of 6-minute walk distance (6MWD: 26 meter) or of forced expiratory volume in 1 second (FEV1: 100ml) or of St. Georges Respiratory Questionnaire total score (SGRQ: 4 points).
- •Subject has marked dyspnea scoring ≥2 on mMRC scale of 0-
- •Subject has stopped smoking for at least 6 months prior to entering the study.
- •Subject read, understood and signed the Informed Consent form.
- •Subject has completed a pulmonary rehabilitation program within 6 months prior to treatment and/or regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 6 months prior to baseline testing.
- •Subject has received Influenza vaccinations consistent with local recommendations and/or policy.
排除标准
- •Subject has co-morbidities that may significantly reduce subject's ability to improve exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea.
- •Subject has severe gas exchange abnormalities as defined by:
- •PaCO2 >8.0 kPa; PaO2 < 6.0 kPa (room air).
- •Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment.
- •Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >50 mm Hg via echocardiogram.
- •Subject has an inability to walk >140 meters in 6 minutes.
- •Subject has evidence of other severe disease (such as, but not limited to, lung cancer or renal failure), which in the judgment of the investigator may compromise survival of the subject for the duration of the study.
- •Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
- •Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia.
- •Subject has clinically significant bronchiectasis.
- •Subject has giant bullae >1/3 lung volume.
- •Subject has had previous LVR surgery, lung transplantation or lobectomy.
- •Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
- •Subject is taking >20 mg prednisone (or equivalent dose of a similar steroid) daily.
- •Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.
- •Subject is on an antiplatelet (such as Plavix) or anticoagulant therapy (such as heparin or Coumadin) which cannot be stopped for 7 days prior to procedure.
- •Subject has a sensitivity or allergy to Nickel.
- •Subject has a known sensitivity to drugs required to perform bronchoscopy.
- •Subject has any other disease, condition(s) or habit(s) that would interfere with completion of study and follow up assessments, would increase risks of bronchoscopy or assessments, or in the judgment of the investigator would potentially interfere.
结局指标
主要结局
Number and type of adverse effects as a measure of safety between baseline and 6 months follow up
时间窗: Baseline - 6 month follow up
The safety objective of this study is to identify the potential number and type of device-related and procedure-related adverse effects.
次要结局
- Change from Baseline in Quality of life at 2 months(Baseline vs 2 month follow up)
- Change from Baseline in functional measures at 2 months(Baseline vs 2 month follow up)
- Change from Baseline in quality of life at 6 months(Baseline vs 6 month follow up)
- Change from Baseline in functional measures at 6 months(Baseline vs 6 month follow up)
- Change from Baseline in Lung function at 2 months(Baseline vs 2 month follow up)
- Change from Baseline in Lung function at 6 months(Baseline vs 6 month follow up)
研究者
Dirk-Jan Slebos
MD PhD
University Medical Center Groningen