Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice Prosthesis

Atos Medical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Total Laryngectomy

Treatments: Device: Provox voice prosthesis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00743262

UD778

Details and patient eligibility

About

The purpose of this study is to investigate the performance of a new voice prosthesis in comparison with the Provox2 and the Provox ActiValve voice prosthesis in 15 laryngectomized patients. Factors taken into account are clinician and patient satisfaction with the insertion system, patient satisfaction with voice, speech, performance, and maintenance. Voice and speech will also be evaluated for the different prostheses by means of perceptual evaluations and acoustic analysis.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Total laryngectomy
• Use Provox ActiValve

Exclusion criteria

• Current problems with TE puncture

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Provox voice prosthesis

Experimental group

Treatment:

Device: Provox voice prosthesis