Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

NCT00396617 | Unknown Phase 1

• 1 other identifier: 3736
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• Phonology's measures

  months 1, 3,12

Interventions

prothesis voice DEVICE

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.

total laryngectomy PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age more than 18
• total laryngectomy or pharyngo-larynctomy

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

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

Strasbourg, 67082, France

RECRUITING

MeSH Terms

Conditions

Pharyngeal Neoplasms; Laryngeal Neoplasms; Carcinoma; Laryngeal Diseases

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Christian DEBRY, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian DEBRY, MD

CONTACT

33.3.88.12.76.44; christian.debry@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2006
• First Posted: November 7, 2006
• Study Start: December 1, 2007
• Primary Completion: September 1, 2013
• Study Completion: March 1, 2014
• Last Updated: July 2, 2012

Record last verified: 2012-06

Locations

FR (1)