Electromyographic Activity of Masseter Muscle During Degl... | NCT01095289

Studies
Electromyographic Activity of Masseter Muscle During Deglutition in Total Laryngectomized Subjects

NCT01095289

Sponsor

Universidade Federal de Pernambuco

Status

Completed

Last Update Posted

Mar 30, 2010Estimated

Enrollment

16Actual

Phase

Not provided

Conditions

Head and Neck Cancer

Interventions

Not provided

Countries

Brazil

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

Jan 2010

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 2010

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Mar 29, 2010

First Submission Date that Met QC Criteria

Mar 29, 2010

First Posted Date

Mar 30, 2010Estimated

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 29, 2010

Last Update Posted Date

Mar 30, 2010Estimated

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

The objective of this study is to evaluate the electromyographic activity of masseter muscle during deglutition in laryngectomized subjects.

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

16Actual

Label	Type	Description	Intervention Names
Total Laryngectomized

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

laryngectomy

Exclusion Criteria:

neurological diseases
no oral feeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

16 subjects underwent total laryngectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leandro Pernambuco, Graduated	Universidade Federal de Pernambuco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Hospital of Pernambuco		Recife	Pernambuco		Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22030975	Derived	Pernambuco Lde A, Silva HJ, Nascimento GK, Silva EG, Balata PM, Santos Vda S, Leao JC. Electrical activity of the masseter during swallowing after total laryngectomy. Braz J Otorhinolaryngol. 2011 Sep-Oct;77(5):645-50. doi: 10.1590/s1808-86942011000500018.

ID	Term
D006258	Head and Neck Neoplasms
D007822	Laryngeal Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D007818	Laryngeal Diseases