Tympanometric Analysis in Cleft Palate | NCT01820689

Studies
Tympanometric Analysis in Cleft Palate

NCT01820689

Sponsor

Centro de Diagnostico Auditivo de Cuiaba

Status

Completed

Last Update Posted

Mar 29, 2013Estimated

Enrollment

16Actual

Phase

Not Applicable

Conditions

Bilateral Complete Cleft Lip and/or Alveolus

Interventions

Tympanometry measurement

Countries

Not provided

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

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Sep 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Mar 18, 2013

First Submission Date that Met QC Criteria

Mar 26, 2013

First Posted Date

Mar 29, 2013Estimated

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

Mar 26, 2013

Last Update Posted Date

Mar 29, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Priscila de Araujo Lucas Rodrigues, Doctor, Centro de Diagnostico Auditivo de CuiabaPrincipal Investigator

Lead Sponsor

Centro de Diagnostico Auditivo de CuiabaOTHER

Collaborators

Name	Class
Federal University of Mato Grosso	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Purpose: Characterize the profile of tympanometric patients with cleft lip and palate in the post surgery period and correlate it with the time of palatoplasty. Methods: The sample consisted of 16 patients with cleft lip or palate totaling 32 ears treated at a Public University Hospital in Cuiabá (MT)- Brazil, in the post surgery moment that varied from three months to 33 years. Were sampled patients of both sexes, pediatrics and adults.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tympanometry measurement	Experimental		Other: Tympanometry measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tympanometry measurement	Other	The tympanometry measurement will be verify and compared with the time of palatoplasty.	Tympanometry measurement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tympanic membrane mobility	Tympanic membrane mobility will be measured through the tympanometry and will be demonstrated through their complacency in ml.	3 months to 33 years

Secondary Outcomes

Measure	Description	Time Frame
Time of palatoplasty		3 months to 33 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cleft incisive trans unilateral or bilateral
post-foramen complete or incomplete

Exclusion Criteria:

isolated cleft lip
associated syndromes
malformation of ear

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided