Establishment of an Artificial Larynx After Total Laryngectomy

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-10-31

Brief Summary

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This study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing.

Detailed Description

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Conditions

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Carcinomatous Disease

Keywords

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laryngectomy artificial larynx breathing swallowing upper airway

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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PROTIP MEDICAL ( Artificial larynx prosthesis)

establishment of an artificial larynx prosthesis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Anyone over 18 years, male or female, with a carcinomatous disease of the upper airways requiring a total laryngectomy

Exclusion Criteria

* Less than 18 years
* Contraindications to general anesthesia
* Any situation considered by the physician operator as an exclusion
* Pregnant women
* Lactating women
* Subglottic or basi-lingual tumor extension more than 1 cm
* Prior radiotherapy
* Severe coagulation disorders

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christian DEBRY, PU-PH

Role: CONTACT

Phone: 03.88.12.76.45

Email: [email protected]

Other Identifiers

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4493

Identifier Type: -

Identifier Source: org_study_id