NCT01720680已完成不适用
Open-label, Prospective Exploratory Study to Assess the Effects of the AlphaCore® Device on Central and Peripheral Airway Dimensions in Patients With COPD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Changes in functional imaging parameters
研究概览
简要总结
- Title: Open-label, prospective exploratory study to assess the effects of the AlphaCore® device on central and peripheral airway dimensions in patients with COPD.
- Indication: COPD patients
- Study Design: Open-label, prospective design
- Study Phase: II
- Test treatment duration: 1 day
- Test treatment: AlphaCore® device
- Dosage regimen: 1 session of stimulation during 90 seconds
- Patient number: up to 10 evaluable patients with COPD
- Patient age: ≥ 18 years
- Sex: male or female
- Primary objective: The evaluation of the effect of the AlphaCore® device on central and peripheral airway dimensions with Computational Fluid Dynamics (CFD).
- Secondary objectives: The assessment of the effect of the AlphaCore® device on lung function (spirometry, diffusion and resistance) and on patient reported outcomes (PRO's).
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a documented diagnosis of COPD
- •Male or female patients aged ≥18 years
- •Patients with a co-operative attitude to be treated with the AlphaCore® device
- •Patients should take anti-cholinergics
- •Female patient of childbearing potential who confirm to use a contraception method during the study
- •Written informed consent obtained
排除标准
- •Pregnant or lactating females or females at risk of pregnancy at screening and not willing to use an appropriate contraception method during the study period
- •Inability to carry out pulmonary function testing
- •Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
- •Patients with an electrical and/or neurostimulator device (e.g. a cardiac pacemaker, a vagal neurostimulator, a defibrillator, a cochlear implant, …)
- •Patients with an abscess or other infection or lesion (incl. lymphadenopathy) at the therapy head placement site
- •Patients with a compromised cervical anatomy (such as from scaring, infection or suspected carotid artery disease) or a cervical vagotomy
- •Patients with a history of carotid endarterectomy or vascular neck surgery on the right side
- •Patients with coagulopathy, irregular heart rhythm or that are on pressor medication
- •Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
- •Patients who received any investigational new drug within the last 4 weeks prior to the screening visit
- •Patients treated with any non-permitted concomitant medication
结局指标
主要结局
Changes in functional imaging parameters
时间窗: At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device
The primary objective of this study is to evaluate the effect of the AlphaCore® on central and peripheral airway dimensions with functional imaging using airway segmentation and computational methods (CFD).
次要结局
- Changes in lung function parameters(At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device)
- Changes in patient reports outcomes (PROs)(At V2 before treatment with the AlphaCore device and at follow-up visit (14 days after visit 2))
研究者
Wilfried De Backer
Prof. Dr.
University Hospital, Antwerp
研究点 (2)
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