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

This study has been terminated.
(Primary endpoint reached, slow accrual, leakage around)
The Netherlands Cancer Institute
Information provided by (Responsible Party):
Atos Medical AB Identifier:
First received: April 9, 2008
Last updated: January 30, 2017
Last verified: January 2017
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.

Condition Intervention
Total Laryngectomy
Device: Provox Vega voice prosthesis (20 Fr)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)

Further study details as provided by Atos Medical AB:

Primary Outcome Measures:
  • Device Life Time [ Time Frame: at replacement of voice prosthesis (maximum 1 year) ]
    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 Outcome Measures:
  • Voice Quality [ Time Frame: at 3 months or device change (whichever was first) ]
    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.

  • Ease of Insertion [ Time Frame: assessed immediately after insertion procedure ]
    The Vega voice prosthesis used in this study is inserted with a new insertion tool, the SmartInserter. Physicians were asked to rate the insertion on a 4 point scale. what they thought of the new insertion tool, also in comparison to the regular tool used in the clinic, the Provox2 inserter. As the Provox voice prosthesis is a tool physicians already used, no insertions were performed with the Provox2 inserter during the study.

  • Reason for Replacement [ Time Frame: At removal of prosthesis ]

Enrollment: 26
Study Start Date: March 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early feasability arm 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
Other Name: indwelling Provox voice prosthesis


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • current puncture problems (f. ex. infection)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00661570

Netherlands Cancer Institute
Amsterdam, Noord-Holland, Netherlands, 1066CX
Sponsors and Collaborators
Atos Medical AB
The Netherlands Cancer Institute
Principal Investigator: Frans JM Hilgers, MD, PhD The Netherlands Cancer Institute
Principal Investigator: Michiel WM van den Brekel, MD, PhD The Netherlands Cancer Institute
  More Information

Responsible Party: Atos Medical AB Identifier: NCT00661570     History of Changes
Other Study ID Numbers: UD736
Study First Received: April 9, 2008
Results First Received: August 2, 2010
Last Updated: January 30, 2017

Keywords provided by Atos Medical AB:
larynx cancer processed this record on April 21, 2017