COPDNCT01720680
Prospective Exploratory Study to Assess the Effects of the AlphaCore® Device in Patients With COPD
A study testing Low dose multislice CT thorax and AlphaCore® device in people with COPD, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Low dose multislice CT thorax and AlphaCore® device
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Prospective Exploratory Study to Assess the Effects of the AlphaCore® Device on Central and Peripheral Airway Dimensions in Patients With COPD
- 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
- Being tested
- Low dose multislice CT thorax, AlphaCore® device
- Keywords
- COPD, Functional Imaging, Patient Reported Outcome (PRO), Lung Function, AlphaCore, Computational Fluid Dynamics
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose multislice CT thoraxRadiation
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".
AlphaCore® deviceDevice
All patients will receive a stimulation therapy of 90 seconds delivered by the AlphaCore.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device
Secondary outcomes (2)
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.
Measured: At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device
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.
Measured: At V2 before treatment with the AlphaCore device and at follow-up visit (14 days after visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilfried De Backer, University Hospital, Antwerp
- Investigators
- Wilfried De Backer, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720680
- Sponsor's protocol ID
- PML_DOC_1202
- Status last verified
- Jun 2013
- First submitted
- 25 Oct 2012
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Prospective Exploratory Study to Assess the Effects of the AlphaCore® Device on Central and Peripheral Airway Dimensions in Patients With COPD
- ClinicalTrials.gov ID
- NCT01720680
- Acronym / sponsor ID
- PML_DOC_1202
- Conditions
- COPD
- Keywords
- COPD, Functional Imaging, Patient Reported Outcome (PRO), Lung Function, AlphaCore, Computational Fluid Dynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose multislice CT thoraxAll 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". | Radiation | – |
| AlphaCore® deviceAll patients will receive a stimulation therapy of 90 seconds delivered by the AlphaCore. | Device | – |
Primary outcome
Changes in functional imaging parameters
Time frame: 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).
2 secondary outcomes
Changes in lung function parameters
Time frame: At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device
Changes in patient reports outcomes (PROs)
Time frame: At V2 before treatment with the AlphaCore device and at follow-up visit (14 days after visit 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilfried De Backer, MD, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose multislice CT thorax and AlphaCore® device in people with COPD, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in functional imaging parameters (time frame: At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2013.