ENTegral Artificial Larynx Clinical Trial

Not Applicable

Terminated

• Conditions: Total Laryngectomy
• Interventions: Device: ENTegral Artificial Larynx implant

• Registration Number: NCT01948219
• Lead Sponsor: ProTiP Medical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-16
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-23
• Study Start: 2014-10
• Primary Completion: 2016-06-30
• Study Completion: 2016-06-30
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ENTegral Artificial Larynx implant	ENTegral Artificial Larynx implant	ENTegral Artificial Larynx implantation

Primary Outcome Measures

Name	Time	Method
Feasibility of device implant procedure	1 year	Number of patients with adverse event associated with device implantation procedure

Trial Locations

Locations (3)

CHU Mont-Godinne; 🇧🇪 Yvoir, Belgium

CHU Toulouse; 🇫🇷 Toulouse, France

CHU Strasbourg; 🇫🇷 Strasbourg, France