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Establishment of an Artificial Larynx After Total Laryngectomy (LA)

Primary Purpose

Carcinomatous Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PROTIP MEDICAL ( Artificial larynx prosthesis)
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinomatous Disease focused on measuring laryngectomy, artificial larynx, breathing, swallowing, upper airway

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue MolièreRecruiting

Outcomes

Primary Outcome Measures

Evaluation of the restoration of respiratory functions
4 items will be used: 0: no dyspnea 1: moderate dyspnea 2: significant dyspnea 3: major dyspnea
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

Secondary Outcome Measures

Full Information

First Posted
October 20, 2011
Last Updated
June 28, 2012
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT01474005
Brief Title
Establishment of an Artificial Larynx After Total Laryngectomy
Acronym
LA
Official Title
Establishment of an Artificial Larynx After Total Laryngectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinomatous Disease
Keywords
laryngectomy, artificial larynx, breathing, swallowing, upper airway

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
PROTIP MEDICAL ( Artificial larynx prosthesis)
Intervention Description
establishment of an artificial larynx prosthesis
Primary Outcome Measure Information:
Title
Evaluation of the restoration of respiratory functions
Description
4 items will be used: 0: no dyspnea 1: moderate dyspnea 2: significant dyspnea 3: major dyspnea
Time Frame
one year
Title
Evaluation of the restoration of the ability to swallow by nasofibroscopy
Description
3 items will be used: 1: no aspiration 2: moderate aspiration 3: massive aspiration
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian DEBRY, PU-PH
Phone
03.88.12.76.45
Ext
33
Email
christian.debry@chru-strasbourg.fr
Facility Information:
Facility Name
Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière
City
Strasbourg
ZIP/Postal Code
67091 Strasbourg Cedex
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian DEBRY, PU-PH
First Name & Middle Initial & Last Name & Degree
Patrick HEMAR, PH
First Name & Middle Initial & Last Name & Degree
Philippe SCHULTZ, PU-PH

12. IPD Sharing Statement

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Establishment of an Artificial Larynx After Total Laryngectomy

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