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Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Pharyngeal Neoplasms, Laryngeal Neoplasms, Carcinoma

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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

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