At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 33 enrolled
Drug / intervention
Provox Vega voice prosthesis 22.5 Frdevice
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.
Amendment on Phase 1 Trial N07VEG "Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)". Amendment 3: Long-term Use of the Provox Vega
In Brief
A Phase 2 clinical trial evaluating Provox Vega voice prosthesis 22.5 Fr for Total Laryngectomy. Completed, enrolled 33 participants across 1 site.
Detailed Summary
The purpose of this study was to investigate the long-term feasibility of the new Provox Vega 22.5 voice prosthesis (outer diameter of 22.5 French) and its insertion system (SmartInserter) in laryngectomized patients who currently use a Provox2 voice prothesis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTotal Laryngectomy
CountriesNetherlands
CollaboratorsThe Netherlands Cancer Institute
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedApr 2009
Primary CompletionMar 2010
TodayJul 2026
First PostedApr 21, 2009
Enrollment StartFeb 1, 2008
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 17.2 years ago
Interventions
Provox Vega voice prosthesis 22.5 Frdevice
The patients' current Provox2 voice prosthesis will be removed and the new Provox Vega voice prosthesis will be inserted.