ENTegral Clinical Trial
This trial is active, not recruiting.
|Treatment||entegral artificial larynx implant|
|Start date||October 2014|
|End date||June 2016|
|Trial size||15 participants|
|Trial identifier||NCT01948219, LA-01-PEC-1|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
ENTegral Artificial Larynx implantation
Feasibility of device implant procedure
time frame: 1 year
Male or female participants at least 18 years old.
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
|Official title||An Evaluation of the ENTegral Artificial Larynx (AL) in Patients Indicated for Total Laryngectomy|
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