Establishment of an Artificial Larynx After Total Laryngectomy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01474005
• Date of registration: 20/10/2011
• Prospective Registration: No
• Primary sponsor: University Hospital, Strasbourg, France
• Public title: Establishment of an Artificial Larynx After Total Laryngectomy LA
• Scientific title: Establishment of an Artificial Larynx After Total Laryngectomy
• Date of first enrolment: October 2011
• Target sample size: 5
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01474005
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Christian DEBRY, PU-PH

Key inclusion & exclusion criteria

Inclusion Criteria:

- Anyone over 18 years, male or female, with a carcinomatous disease of the upper
airways requiring a total laryngectomy

Exclusion Criteria:

- Less than 18 years

- Contraindications to general anesthesia

- Any situation considered by the physician operator as an exclusion

- Pregnant women

- Lactating women

- Subglottic or basi-lingual tumor extension more than 1 cm

- Prior radiotherapy

- Severe coagulation disorders



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Carcinomatous Disease

Intervention(s)

Device: PROTIP MEDICAL ( Artificial larynx prosthesis)

Primary Outcome(s)

Evaluation of the restoration of the ability to swallow by nasofibroscopy [Time Frame: one year]

Evaluation of the restoration of respiratory functions [Time Frame: one year]

Secondary ID(s)

4493

Source(s) of Monetary Support

Please refer to primary and secondary sponsors