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Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

Primary Purpose

Pharyngeal Neoplasms, Laryngeal Neoplasms, Carcinoma

Status

Unknown status

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

prothesis voice

total laryngectomy

About this trial

This is an interventional treatment trial for Pharyngeal Neoplasms focused on measuring Laryngeal or pharyngo-laryngeal's carcinoma,, voice prosthesis tracheooesophageal shunt,, titanium beads,, cellular colonization, Laryngeal or pharyngo-laryngeal's carcinoma

Eligibility Criteria

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

Inclusion criteria:

age more than 18
total laryngectomy or pharyngo-larynctomy

Exclusion criteria:

pregnant women-age less than 18
major pulmonary bronchitis
major neurological disorders

Sites / Locations

Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, Hôpitaux Universitaires de StrasbourgRecruiting

Outcomes

Primary Outcome Measures

Clinical measures concerning peri and intra prosthetic leakage

Secondary Outcome Measures

Phonology's measures

Full Information

NCT ID

NCT00396617

First Posted

November 6, 2006

Last Updated

June 28, 2012

Sponsor

University Hospital, Strasbourg, France

Collaborators

OseoAnvar, Réseau National des Technologies de Santé

1. Study Identification

Unique Protocol Identification Number

NCT00396617

Brief Title

Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

Official Title

Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Unknown status

Study Start Date

December 2007 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Strasbourg, France

Collaborators

OseoAnvar, Réseau National des Technologies de Santé

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The benefits of this new material, as demonstrated in animal studies and preliminary studies in man, could provide the answer to problems encountered by surgeons in the field of phonatory implants. This novel application is a step towards resolving the very real problems which still exist in the field today. The functional concept, which will allow better control over integrating implants in tissue, should also, it is hoped, favour cellular colonization, thereby fulfilling a currently unmet medical need. The aim is to avoid well-identified potential complications linked to the use of silicone-only implants (with or without a surface coating), like leakage around the prosthesis (by cellular colonization), and so reduce the risk of protrusion/extrusion of the prosthesis as far as possible, and to avoid trauma to the peri-prosthetic tissues by repeated interventions

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pharyngeal Neoplasms, Laryngeal Neoplasms, Carcinoma

Keywords

Laryngeal or pharyngo-laryngeal's carcinoma,, voice prosthesis tracheooesophageal shunt,, titanium beads,, cellular colonization, Laryngeal or pharyngo-laryngeal's carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

14 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

prothesis voice

Intervention Description

The device may be used for patient using another type of voice prosthesis, of for patient undergoing total laryngectomy. This device is definitively placed in two parts:The first one is introduced in the puncture (TEP) through the esophagus (retrograde way). The second part is then clipped on the first one through the tracheotomy orifice (anterograde way).A third part containing the valve can then be clipped in the prosthesis and easily removed in order to change it as often as necessary.

Intervention Type

Procedure

Intervention Name(s)

total laryngectomy

Intervention Description

The second part is then clipped on the first one through the tracheotomy orifice (anterograde way).A third part containing the valve can then be clipped in the prosthesis and easily removed in order to change it as often as necessary.

Primary Outcome Measure Information:

Title

Clinical measures concerning peri and intra prosthetic leakage

Time Frame

days 8,15,21,30 - months : 2 ,4,6,8, 10, 12, 15,18,21,24,30, 36

Secondary Outcome Measure Information:

Title

Phonology's measures

Time Frame

months 1, 3,12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: age more than 18 total laryngectomy or pharyngo-larynctomy Exclusion criteria: pregnant women-age less than 18 major pulmonary bronchitis major neurological disorders

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christian DEBRY, MD

Phone

33.3.88.12.76.44

christian.debry@chru-strasbourg.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian DEBRY, MD

Organizational Affiliation

Hôpitaux Universitaires de Strasbourg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

City

Strasbourg

ZIP/Postal Code

67082

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christian DEBRY, MD

Phone

33.3.88.12.76.44

christian.debry@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Patrick HEMAR, MD

First Name & Middle Initial & Last Name & Degree

Philippe SCHULTZ, MD

First Name & Middle Initial & Last Name & Degree

Christian DEBRY, MD

12. IPD Sharing Statement

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Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

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