CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Provox voice prosthesisdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00743262
NCT00743262Phase 2Completed
CompareCT.gov

Second Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)': Vega Siri Addendum.

Atos Medical AB·interventional·Posted Aug 28, 2008·Updated Jul 25, 2023

In Brief

A Phase 2 clinical trial evaluating Provox voice prosthesis for Total Laryngectomy. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTotal Laryngectomy
CountriesNetherlands
CollaboratorsThe Netherlands Cancer Institute

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 28, 2008
Enrollment StartApr 1, 2008
Primary CompletionAug 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.8 years ago

Interventions

Provox voice prosthesisdevice

The current voice prosthesis (Provox ActiValve)of the patients will be removed and a new prosthesis (Provox Vega) will be inserted