Clinical trial · Interventional
Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis
Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)
NCT00661570CI-TRIAL-00026390terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Primary endpoint reached, slow accrual, leakage around
Summary
Brief summary (as posted)
The purpose of this study is to investigate long-term clinical feasibility of a new voice prosthesis and insertion system Provox Vega 20 with SmartInserter) for voice rehabilitation after total laryngectomy. Outcome measures are voice quality, ease of insertion, device life, and reason for replacement.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Total Laryngectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Provox Vega voice prosthesis (20 Fr) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Early feasability arm
- interventionNames
- Device: Provox Vega voice prosthesis (20 Fr)
Primary outcomes (1)
- measure
- Device Life Time
- timeFrame
- at replacement of voice prosthesis (maximum 1 year)
- description
- Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time.
Secondary outcomes (3)
- measure
- Voice Quality
- timeFrame
- at 3 months or device change (whichever was first)
- description
- Subjective patient opinion about 5 voice related items (intelligibility face to face and on the phone, loudness, pitch and fluency). The best value is 5 and the worst value is 20.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * total laryngectomy * use Provox2 voice prosthesis * at least two prior prosthesis changes Exclusion Criteria: * current puncture problems (f. ex. infection)
References
Publications (0)
Data not yet available
No reference posted for this study.