ENTegral Artificial Larynx Clinical Trial

NCT ID: NCT01948219

Last Updated: 2018-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Total Laryngectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ENTegral Artificial Larynx implant

ENTegral Artificial Larynx implantation

Group Type EXPERIMENTAL

ENTegral Artificial Larynx implant

Intervention Type DEVICE

Interventions

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ENTegral Artificial Larynx implant

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ProTiP Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Mont-Godinne

Yvoir, , Belgium

Site Status

CHU Strasbourg

Strasbourg, , France

Site Status

CHU Toulouse

Toulouse, , France

Site Status

Countries

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Belgium France

Other Identifiers

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LA-01-PEC-1

Identifier Type: -

Identifier Source: org_study_id

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