Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Hospital, Antwerp
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Prospective Exploratory Study to Assess the Effects of the AlphaCore® Device in Patients With COPD
