Establishment of an Artificial Larynx After Total Laryngectomy (LA)

University Hospital, Strasbourg, France

Status: Unknown

Conditions: Carcinomatous Disease

Treatments: Device: PROTIP MEDICAL ( Artificial larynx prosthesis)

Study type: Interventional

Funder types: Other

Identifiers

NCT01474005

4493

Details and patient eligibility

About

This study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing.

Enrollment: 5 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)