NCT00640120

Brief Summary

The WIM-PC™ device, indicated for acoustic pulmonary function measurement that quantifies the presence of wheezing. This study was designed in order to evaluate the efficacy and safety of using the WIM-PC™ device for wheeze detection during dynamic bronchial situations in infants that were hospitalized as a result of asthmatic attack.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

June 9, 2011

Status Verified

March 1, 2008

Enrollment Period

4 months

First QC Date

March 15, 2008

Last Update Submit

June 8, 2011

Conditions

Asthma, Bronchial

Keywords

wheeze detection

Outcome Measures

Primary Outcomes (1)

  • Study success will be declared if one of the following is met: A correlation of at least 0.25 (R2=0.25) will be found between WR and FEV1 measurements; A correlation of at least 0.7 will be found between clinical parameter and WZ measurements.

    6 months

Secondary Outcomes (1)

  • Evaluation of the safety of using the WIM-PC™ for wheeze detection. Safety will be established by lack of adverse events. Since this is a Non Significant Risk (NSR) device serious adverse events are not expected

    6 months

Study Arms (2)

1

Asthmatic subjects

Device: WIM-PC™ device

2

Healthy subjects

Device: WIM-PC™ device

Interventions

WIM-PC™ deviceDEVICE

wheeze detection during dynamic bronchial situations in infants

12

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

asthmatic subjects or healthy subjects

You may qualify if:

  • Asthmatic or healthy subjects;
  • Age up to 18 years;
  • Subject or subject's parents/guardian is able to comprehend and give informed consent for participation in the study.

You may not qualify if:

  • Chest lesions (rush or deformity);
  • Hemodynamic instability;
  • Concurrent additional major illness.
  • Concurrent participation in any other clinical study.
  • Physician objection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnei-Zion Medical Center

Haifa, 31048, Israel

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Noam Gavriely, Prof.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 15, 2008

First Posted

March 21, 2008

Study Start

July 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

June 9, 2011

Record last verified: 2008-03

Locations

IL(1)