Prospective Exploratory Study to Assess the Effects of the AlphaCore® Device in Patients With COPD

Antwerp University Hospital (UZA)

Status

Completed

Conditions

COPD

Treatments

Radiation: Low dose multislice CT thorax

Device: AlphaCore® device

Study type

Interventional

Funder types

Other

Identifiers

PML_DOC_1202

Details and patient eligibility

About

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).

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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