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.

Study Overview

• Status: Terminated
• Conditions: Total Laryngectomy
• Intervention / Treatment: Device: ENTegral Artificial Larynx implant

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Yvoir, Belgium, 5530
    • CHU Mont-Godinne
• France
  • Strasbourg, France, 67000
    • CHU Strasbourg
  • Toulouse, France, 31000
    • Chu Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ENTegral Artificial Larynx implant; ENTegral Artificial Larynx implantation	Device: ENTegral Artificial Larynx implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of device implant procedure	Number of patients with adverse event associated with device implantation procedure	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Quality of life using EORTC QLQ-C30 and QLQ-H&N25 questionnaires	1, 3, 6 months and 1 year
Number of patients with adverse events	Number of patients with adverse events will be assessed at each follow-up during the 1 year patient follow-up	1 year
Dyspnea evolution	Dyspnea evaluation using the Heyse-Moore scale at 1, 2, 3, 6, 9 months and 1 year	1,2,3,6,9 months and 1 year
Phonation evolution	Patient phonation (able to talk and be understood, whispered voice) will be assessed at 1, 2, 3, 6, 9 months and 1 year	1,2,3,6,9 months and 1 year
Implant use	Implant use (manual closure of the tracheostomy orifice) duration will be assessed at 1, 2, 3, 6, 9 months and 1 year, allowing eventually to surgically close the orifice	1,2,3,6,9 months and 1 year

Collaborators and Investigators

• Sponsor: ProTiP Medical

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): June 30, 2016
• Study Completion (Actual): June 30, 2016

Study Registration Dates

• First Submitted: September 16, 2013
• First Submitted That Met QC Criteria: September 18, 2013
• First Posted (Estimate): September 23, 2013

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: LA-01-PEC-1