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Artificial Larynx : Intralaryngeal Prosthesis With Valve in Major Swallowing Troubles


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Swallowing Disorders, Dysphagia, Laryngeal Neoplasms

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Trial Information

Artificial Larynx : Intralaryngeal Prosthesis With Valve in Major Swallowing Troubles

Inclusion Criteria


Inclusion criteria:

- Age more than 18

- Swallowing troubles

Exclusion criteria:

- Pregnant women

- Contraindications to general anesthesia

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Respiratory evaluation

Outcome Time Frame:

Day : 1, 2, 3, 4, 5, 15 - month :1, 3, 6, 12, 18, 24, 30, 36

Safety Issue:

Yes

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:

3866

NCT ID:

NCT00576134

Start Date:

February 2008

Completion Date:

February 2013

Related Keywords:

  • Swallowing Disorders
  • Dysphagia
  • Laryngeal Neoplasms
  • Larynx, tracheotomy, titanium beads
  • Neoplasms
  • Deglutition Disorders
  • Laryngeal Neoplasms

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