Very Long Term VHI Voice Outcome After MTIS | NCT02969993

Studies
Very Long Term VHI Voice Outcome After MTIS

NCT02969993

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Last Update Posted

Mar 20, 2018Actual

Enrollment

53Actual

Phase

Not Applicable

Conditions

Laryngeal Paralysis

Interventions

Questionnaires

Countries

Belgium
Spain

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 2018

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

Dec 2016

Primary Completion Date

Oct 17, 2017Actual

Completion Date

Oct 19, 2017Actual

First Submitted Date

Nov 18, 2016

First Submission Date that Met QC Criteria

Nov 18, 2016

First Posted Date

Nov 21, 2016Estimated

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 19, 2018

Last Update Posted Date

Mar 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Long term assesment of voice outcome after Montgomery Thyroplastie by performing a Survey of operated patients using the voice handicap index scale

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

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Questionnaire	Experimental	Questionnaire to previously operated patients	Other: Questionnaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaires	Other	evaluating the voice outcome by the fullfilment of the voice handicap index	Questionnaire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Voice handicap index	Questionnaire	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients presenting UVFP of neurogenic origin treated by MTIS > 2 years before inclusion.
No superior limit in terms of years.
Age 18-80 years at the time of MTIS
No other treatment before MTIS other than resorbing material injection laryngoplasty (maximum twice)
No further voice treatment after MTIS except speech therapy.
VHI or VHI-10 performed before MTIS and within the 6 months after MTIS. In case of multiple post-op VHI tests, only the earliest post-op. VHI test will be taken into account
VHI tests validated for the utilized language

Exclusion Criteria:

patient not able to answer VHI questionnaire personally
Post MTIS new health condition affecting the voice tract and/ or the respiratory function.
Post MTIS appearance of other voice/ vocal cord pathology

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques universitaires Saint-Luc		Brussels Capital Region	Brussels Capital	1200	Belgium
CHU Namur -Mont-Godinne

Condition Browse Module

MeSH Terms

ID	Term
D014826	Vocal Cord Paralysis

Ancestor Terms

ID	Term
D007818	Laryngeal Diseases
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases
D020421	Vagus Nerve Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided