Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00396617
• Collaborator: OseoAnvar (Other), Réseau National des Technologies de Santé (Other)
• Enrollment: 14
• Location: 1
• Duration (Months): 75
• Patients Per Site Per Month: 0.2

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Pharyngeal Neoplasms; Laryngeal Neoplasms; Carcinoma	Device: prothesis voice; Procedure: total laryngectomy	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 14 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy
• Study Start Date: Dec 1, 2007
• Anticipated Primary Completion Date: Sep 1, 2013
• Anticipated Study Completion Date: Mar 1, 2014

Outcome Measures

Primary Outcome Measures

1. Clinical measures concerning peri and intra prosthetic leakage [days 8,15,21,30 - months : 2 ,4,6,8, 10, 12, 15,18,21,24,30, 36]

Secondary Outcome Measures

1. Phonology's measures [months 1, 3,12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg	Strasbourg		France	67082

Sponsors and Collaborators

• University Hospital, Strasbourg, France
• OseoAnvar
• Réseau National des Technologies de Santé

Investigators

• Principal Investigator: Christian DEBRY, MD, Hôpitaux Universitaires de Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT00396617
• Other Study ID Numbers: 3736
• First Posted: Nov 7, 2006
• Last Update Posted: Jul 2, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by University Hospital, Strasbourg, France: Laryngeal or pharyngo-laryngeal's carcinoma,; voice prosthesis tracheooesophageal shunt,; titanium beads,; cellular colonization; Laryngeal or pharyngo-laryngeal's carcinoma
• Additional relevant MeSH terms: Carcinoma; Neoplasms; Laryngeal Neoplasms; Pharyngeal Neoplasms

Study Results

No Results Posted as of Jul 2, 2012