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ENTegral Artificial Larynx Clinical Trial

P

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)

2 participants in 1 patient group

ENTegral Artificial Larynx implant
Experimental group
Description:
ENTegral Artificial Larynx implantation
Treatment:
Device: ENTegral Artificial Larynx implant

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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