ENTegral Artificial Larynx Clinical Trial

N/ATerminatedNCT01948219

ProTiP Medical2 enrolled

Overview

The objective of this clinical study is to evaluate the feasibility, safety and efficacy of the ENTegral Artificial Larynx (AL) in patients indicated for total laryngectomy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Total Laryngectomy

Interventions

ENTegral Artificial Larynx implantDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age more than or equal to 18 years old * Is indicated for total laryngectomy (first intention) * Must be able to comply with study requirements * Must be able to understand and be willing to provide written informed consent Exclusion Criteria: * Any condition that precludes the implantation of the ENTegral AL * Existing coagulation disorder * Contraindication for general anesthesia * Tumoral extension outside of the larynx invading through extra-laryngeal structures * Previous radiotherapy * Life-expectancy \< 12 months * Be pregnant of breastfeeding or intention to becoming pregnant during study

Locations (3)

CHU Mont-Godinne

Yvoir, Belgium

CHU Strasbourg

Strasbourg, France

CHU Toulouse

Toulouse, France

Outcomes

Primary Outcomes

Feasibility of device implant procedure

Number of patients with adverse event associated with device implantation procedure

Time frame: 1 year

Data from ClinicalTrials.gov

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