Establishment of an Artificial Larynx After Total Laryngectomy

University Hospital, Strasbourg, France5 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinomatous Disease

Interventions

PROTIP MEDICAL ( Artificial larynx prosthesis)DEVICE

establishment of an artificial larynx prosthesis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière

Strasbourg, France

RECRUITING

Outcomes

Primary Outcomes

Evaluation of the restoration of respiratory functions

4 items will be used: * 0: no dyspnea * 1: moderate dyspnea * 2: significant dyspnea * 3: major dyspnea

Time frame: one year

Evaluation of the restoration of the ability to swallow by nasofibroscopy

3 items will be used: * 1: no aspiration * 2: moderate aspiration * 3: massive aspiration

Time frame: one year

Central Contacts

Christian DEBRY, PU-PH

CONTACT

03.88.12.76.45 christian.debry@chru-strasbourg.fr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.