ENTegral Artificial Larynx Clinical Trial

An Evaluation of the ENTegral Artificial Larynx (AL) in Patients Indicated for Total Laryngectomy

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.

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