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

NCT01720680 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2013-06-28

No results posted yet for this 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).

Conditions

Interventions

RADIATION

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".

DEVICE

AlphaCore® device

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

Sponsors & Collaborators

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Wilfried De Backer, MD, PhD · University Hospital, Antwerp

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2012-10-31
Completion
2012-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01720680 on ClinicalTrials.gov