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

NCT ID: NCT01720680

Last Updated: 2013-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2012-12-31

Brief Summary

• 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).

Conditions

COPD

Keywords

COPD; Functional Imaging; Patient Reported Outcome (PRO); Lung Function; AlphaCore; Computational Fluid Dynamics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Low dose multislice CT thorax

All patients will have 2 low dose multi-slice CT's at visit 2: one CT "pre-dose" and one CT 1 to 3 hours "post-dose".

Intervention Type: RADIATION

AlphaCore® device

All patients will receive a stimulation therapy of 90 seconds delivered by the AlphaCore.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Wilfried De Backer

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wilfried De Backer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

University Hospital Antwerp

Edegem, Antwerp, Belgium

Countries

Belgium

Other Identifiers

PML_DOC_1202

Identifier Type: -

Identifier Source: org_study_id