Status:
COMPLETED
Long Term Use of the Provox Vega 22.5
Lead Sponsor:
Atos Medical AB
Collaborating Sponsors:
The Netherlands Cancer Institute
Conditions:
Total Laryngectomy
Eligibility:
All Genders
Phase:
PHASE2
Brief 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 laryngec...
Detailed Description
Nowadays, many laryngectomized patients use a voice prosthesis to speak. The Provox2 is an indwelling voice prosthesis that has been on the market since 1997. Recently a new Provox voice prosthesis ha...
Eligibility Criteria
Inclusion
- total laryngectomy
- Provox2 user
- at least two previous replacements
Exclusion
- patients' refusal
- fistula problems
- Provox ActiValve users
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00884910
Start Date
February 1 2008
End Date
March 1 2010
Last Update
July 16 2012
Active Locations (1)
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1
Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands, 1066 CX