Trials / Terminated
TerminatedNCT00661570
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)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Atos Medical AB · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Provox Vega voice prosthesis (20 Fr) | The current Provox2 voice prosthesis of laryngectomized patients will, when the patient comes in for a change, be replaced with a new, next generation Provox Vega voice prosthesis and insertion system |
Timeline
- Start date
- 2008-03-01
- Primary completion
- 2009-03-01
- Completion
- 2009-03-01
- First posted
- 2008-04-18
- Last updated
- 2017-03-10
- Results posted
- 2010-11-03
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT00661570. Inclusion in this directory is not an endorsement.