ENTegral Artificial Larynx Clinical Trial

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01948219

Enrollment

Registered

2013-09-23

Start date

2014-10-31

Completion date

2016-06-30

Last updated

2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Laryngectomy

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.

Interventions

DEVICEENTegral Artificial Larynx implant

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Other

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

Countries

Belgium, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026