Study Results
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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TERMINATED
NA
2 participants
INTERVENTIONAL
2014-10-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ENTegral Artificial Larynx implant
ENTegral Artificial Larynx implantation
ENTegral Artificial Larynx implant
Interventions
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ENTegral Artificial Larynx implant
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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ProTiP Medical
INDUSTRY
Responsible Party
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Locations
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CHU Mont-Godinne
Yvoir, , Belgium
CHU Strasbourg
Strasbourg, , France
CHU Toulouse
Toulouse, , France
Countries
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Other Identifiers
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LA-01-PEC-1
Identifier Type: -
Identifier Source: org_study_id
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