Phase 2
Completed N=15
Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice Prosthesis
Total Laryngectomy
Source: ClinicalTrials.gov NCT00743262 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2010
Primary outcomePrimary: Short-term Feasibility Provox Vega 22.5 French — 15 Patients
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short-term Feasibility Provox Vega 22.5 French |
15 | — |
| SECONDARY Subjective Voice and Speech Quality |
6 | — |
| SECONDARY Device Life Time |
39.7 | — |
Eligibility Criteria
Inclusion Criteria
- Total laryngectomy
- Use Provox ActiValve
Exclusion Criteria
- Current problems with TE puncture
Data sourced from ClinicalTrials.gov (NCT00743262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.