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CompletedNCT01720680Updated Jun 28, 2013

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

An interventional study of Low dose multislice CT thorax and AlphaCore® device in COPD, sponsored by University Hospital, Antwerp. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-28.

Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).
02

Conditions studied

  • COPD

Keywords

  • COPD
  • Functional Imaging
  • Patient Reported Outcome (PRO)
  • Lung Function
  • AlphaCore
  • Computational Fluid Dynamics
03

In context

Lead sponsor

University Hospital, Antwerp is the lead sponsor of 234 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Interventions

  • RadiationLow 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".

  • DeviceAlphaCore® device

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

06

What researchers measure

Primary outcomes

  1. Changes in functional imaging parameters

    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).

    Time frame: At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device

Secondary outcomes

  1. Changes in lung function parameters

    The secondary objectives of this study are to assess the effects after treatment with the AlphaCore® on lung function (spirometry, resistance and diffusion), on COPD Assessment Test (CAT), on Modified Medical Research Council (MMRC), on Saint George's Respiratory Questionnaire (SGRQ) and on health questionnaire EQ-5D-5L.

    Time frame: At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device

  2. Changes in patient reports outcomes (PROs)

    The secondary objectives of this study are to assess the effects after treatment with the AlphaCore® on lung function (spirometry, resistance and diffusion), on COPD Assessment Test (CAT), on Modified Medical Research Council (MMRC), on Saint George's Respiratory Questionnaire (SGRQ) and on health questionnaire EQ-5D-5L.

    Time frame: At V2 before treatment with the AlphaCore device and at follow-up visit (14 days after visit 2)

07

Study locations

1 site
  • University Hospital Antwerp
    Edegem, Antwerp 2650, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01720680
Lead sponsor
University Hospital, Antwerp
Responsible party
Wilfried De Backer (Prof. Dr., University Hospital, Antwerp) — Principal investigator
First posted
Nov 2, 2012
Start date
Oct 2012
Primary completion
Oct 2012
Completion
Dec 2012
Last update
Jun 28, 2013

Study contacts

Wilfried De Backer, MD, PhD
principal investigator · University Hospital, Antwerp

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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