Overview

This trial is active, not recruiting.

Condition total laryngectomy
Treatment entegral artificial larynx implant
Phase phase 2
Sponsor ProTiP Medical
Start date October 2014
End date June 2016
Trial size 15 participants
Trial identifier NCT01948219, LA-01-PEC-1

Summary

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

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ENTegral Artificial Larynx implantation
entegral artificial larynx implant

Primary Outcomes

Measure
Feasibility of device implant procedure
time frame: 1 year

Eligibility Criteria

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

Additional Information

Official title An Evaluation of the ENTegral Artificial Larynx (AL) in Patients Indicated for Total Laryngectomy
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by ProTiP Medical.