WheezoMeter® Correlation Study | NCT01556958

Studies
WheezoMeter® Correlation Study

NCT01556958

Sponsor

iSonea

Status

Terminated

Last Update Posted

Aug 19, 2013Estimated

Enrollment

19Actual

Phase

Not provided

Conditions

Asthma
Bronchiolitis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Device revised

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Mar 15, 2012

First Submission Date that Met QC Criteria

Mar 16, 2012

First Posted Date

Mar 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2013

Last Update Posted Date

Aug 19, 2013Estimated

Description Module

Brief Summary

The primary goal of the study is to more firmly establish correlations between WheezeRate(Wz%) and other parameters used to assess wheezing and asthma including spirometry, provider's auscultation, and symptoms at the time of Wz% measurement.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients <= 12 years of age who have wheezing at the time of study as confirmed by the physicians' auscultation.

Control:

Patients <= 12 years of age without history of asthma or other pulmonary conditions, and who are without wheezing on physical exam.

Exclusion Criteria:

Medical problems that would contraindicate Wz% measurement.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

12 Years

Standard Ages

Child

Study Population

Pediatric Specialty Clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site 1		Folsom	California	95630	United States

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D001988	Bronchiolitis

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Active Wheezing - age 5-12
Active Wheezing - under age 5
No Wheezing