ENTegral Artificial Larynx Clinical Trial

Total Laryngectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01948219
• Other study ID #: LA-01-PEC-1
• Status: Terminated
• Phase: N/A
• First received: September 16, 2013
• Last updated: April 3, 2018
• Start date: October 2014
• Est. completion date: June 30, 2016

Study information

• Verified date: April 2018
• Source: ProTiP Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Laryngectomy

Intervention

Device:
• ENTegral Artificial Larynx implant

Locations

Country	Name	City	State
Belgium	CHU Mont-Godinne	Yvoir
France	CHU Strasbourg	Strasbourg
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
ProTiP Medical

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	Quality of life using EORTC QLQ-C30 and QLQ-H&N25 questionnaires	1, 3, 6 months and 1 year
Other	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
Other	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
Other	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
Other	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
Primary	Feasibility of device implant procedure	Number of patients with adverse event associated with device implantation procedure	1 year