Phase 2
N=33
Long Term Use of the Provox Vega 22.5
Total Laryngectomy
Bottom Line
View on ClinicalTrials.gov: NCT00884910 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Nov 2010
Primary outcome: Primary: Patient Preference — 14; 7; 11 Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Provox Vega voice prosthesis 22.5 Fr (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Atos Medical AB
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Preference |
14; 7; 11 | — |
| SECONDARY Device Life Time |
74 | — |
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.
Eligibility Criteria
Inclusion Criteria
- total laryngectomy
- Provox2 user
- at least two previous replacements
Exclusion Criteria
- patients' refusal
- fistula problems
- Provox ActiValve users
Data sourced from ClinicalTrials.gov (NCT00884910). 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.