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

Phase 1

Completed

• Conditions: Total Laryngectomy
• Interventions: Device: Provox voice prosthesis

• Registration Number: NCT00743262
• Lead Sponsor: Atos Medical AB

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-08
• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-27
• Study First Posted: 2008-08-28
• Study Completion: 2009-04
• Results First Submitted: 2010-08-02
• Results First Submitted QC: 2010-10-13
• Results First Posted: 2010-11-03
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Total laryngectomy
• Use Provox ActiValve

Exclusion Criteria

• Current problems with TE puncture

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Provox voice prosthesis	Provox voice prosthesis	-

Primary Outcome Measures

Name	Time	Method
Short-term Feasibility Provox Vega 22.5 French	3 weeks	Number of participants in whom the voice prosthesis was considered feasible in the short-term with regards to clinical and technical aspects as judged by patient and investigator.

Secondary Outcome Measures

Name	Time	Method
Subjective Voice and Speech Quality	3 weeks	Subjective participant opinion using a structured questionnaire addressing intelligibility face to face and on the phone, loudness, pitch and fluency. Each question was measured on a four point scale. Scores were summated, best possible score is 5, worst possible score is 20.
Device Life Time	one year	Device life time of the Provox Vega in days for replacement for leakage through the device. This is expected to be short (average about 3 weeks) since the Provox Vega 22.5 was tested in patients who normally use a Provox ActiValve. (Provox ActiValve is a problem solving prostheses used in patients who need frequent replacement of regular Provox voice prostheses short that are made of the same materials as the Provox Vega 22.5.)

Trial Locations

Locations (1)

Netherlands Cancer Institute; 🇳🇱 Amsterdam, Noord Holland, Netherlands