Trial Information
Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical measures concerning peri and intra prosthetic leakage
Outcome Time Frame:
days 8,15,21,30 - months : 2 ,4,6,8, 10, 12, 15,18,21,24,30, 36
Safety Issue:
No
Principal Investigator
Christian DEBRY, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hôpitaux Universitaires de Strasbourg
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
3736
NCT ID:
NCT00396617
Start Date:
December 2007
Completion Date:
March 2014
Related Keywords:
- Pharyngeal Neoplasms
- Laryngeal Neoplasms
- Carcinoma
- Laryngeal or pharyngo-laryngeal's carcinoma,
- voice prosthesis tracheooesophageal shunt,
- titanium beads,
- cellular colonization
- Laryngeal or pharyngo-laryngeal's carcinoma
- Neoplasms
- Carcinoma
- Laryngeal Neoplasms
- Pharyngeal Neoplasms