Text Size

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)
Sponsor:
Collaborator:
The Netherlands Cancer Institute
Information provided by:
Atos Medical AB
ClinicalTrials.gov Identifier:
NCT00661570
First received: April 9, 2008
Last updated: October 13, 2010
Last verified: October 2010
History of Changes

April 9, 2008
October 13, 2010
March 2008
March 2009   (final data collection date for primary outcome measure)
Device Life Time [ Time Frame: at replacement of voice prosthesis (maximum 1 year) ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00661570 on ClinicalTrials.gov Archive Site
  • Voice Quality [ Time Frame: at 3 months or device change (whichever was first) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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)

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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Total Laryngectomy
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
26
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • current puncture problems (f. ex. infection)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00661570
UD736
No
Corina van As-Brooks, Clinical Affairs Manager, Atos Medical AB
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
Atos Medical AB
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP