ENTegral Artificial Larynx Clinical Trial

ProTiP Medical

Status: Terminated

Conditions: Total Laryngectomy

Treatments: Device: ENTegral Artificial Larynx implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01948219

LA-01-PEC-1

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

ENTegral Artificial Larynx implant

Experimental group

Description:

ENTegral Artificial Larynx implantation

Treatment:

Device: ENTegral Artificial Larynx implant