Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

University Hospital, Strasbourg, France

Status and phase: Unknown; Phase 1

Conditions: Carcinoma; Pharyngeal Neoplasms; Laryngeal Neoplasms

Treatments: Device: prothesis voice; Procedure: total laryngectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00396617

3736

Details and patient eligibility

About

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

Enrollment: 14 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)