Establishment of an Artificial Larynx After Total Larynge... | NCT01474005

Studies
Establishment of an Artificial Larynx After Total Laryngectomy

NCT01474005

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Jul 2, 2012Estimated

Enrollment

5Estimated

Phase

Not Applicable

Conditions

Carcinomatous Disease

Interventions

PROTIP MEDICAL ( Artificial larynx prosthesis)

Countries

France

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

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Oct 2013Estimated

Completion Date

Oct 2013Estimated

First Submitted Date

Oct 20, 2011

First Submission Date that Met QC Criteria

Nov 14, 2011

First Posted Date

Nov 17, 2011Estimated

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

Jun 28, 2012

Last Update Posted Date

Jul 2, 2012Estimated

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

This study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing.

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

5Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PROTIP MEDICAL ( Artificial larynx prosthesis)	Device	establishment of an artificial larynx prosthesis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of the restoration of respiratory functions	4 items will be used: 0: no dyspnea 1: moderate dyspnea 2: significant dyspnea 3: major dyspnea	one year
Evaluation of the restoration of the ability to swallow by nasofibroscopy	3 items will be used: 1: no aspiration 2: moderate aspiration 3: massive aspiration	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Anyone over 18 years, male or female, with a carcinomatous disease of the upper airways requiring a total laryngectomy

Exclusion Criteria:

Less than 18 years
Contraindications to general anesthesia
Any situation considered by the physician operator as an exclusion
Pregnant women
Lactating women
Subglottic or basi-lingual tumor extension more than 1 cm
Prior radiotherapy
Severe coagulation disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christian DEBRY, PU-PH	Contact	03.88.12.76.45	33	christian.debry@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière	Recruiting	Strasbourg		67091 Strasbourg Cedex	France

Condition Browse Module

MeSH Terms

ID	Term
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided