Status:

TERMINATED

Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis

Lead Sponsor:

Atos Medical AB

Collaborating Sponsors:

The Netherlands Cancer Institute

Conditions:

Total Laryngectomy

Eligibility:

All Genders

Phase:

NA

Brief 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 laryng...

Eligibility Criteria

Inclusion

  • total laryngectomy
  • use Provox2 voice prosthesis
  • at least two prior prosthesis changes

Exclusion

  • current puncture problems (f. ex. infection)

Key Trial Info

Start Date :

March 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2009

Estimated Enrollment :

26 Patients enrolled

Trial Details

Trial ID

NCT00661570

Start Date

March 1 2008

End Date

March 1 2009

Last Update

March 10 2017

Active Locations (1)

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1

Netherlands Cancer Institute

Amsterdam, North Holland, Netherlands, 1066CX