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
  Purpose

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 Phase
Total Laryngectomy
Device: Provox Vega voice prosthesis (20 Fr)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)

Resource links provided by NLM:


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) ] [ 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.


Secondary Outcome Measures:
  • 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 ]

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)
Intervention Details:
    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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00661570

Locations
Netherlands
Netherlands Cancer Institute
Amsterdam, Noord-Holland, Netherlands, 1066CX
Sponsors and Collaborators
Atos Medical AB
The Netherlands Cancer Institute
Investigators
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

No publications provided

Responsible Party: Corina van As-Brooks, Clinical Affairs Manager, Atos Medical AB
ClinicalTrials.gov Identifier: NCT00661570     History of Changes
Other Study ID Numbers: UD736
Study First Received: April 9, 2008
Results First Received: August 2, 2010
Last Updated: October 13, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Atos Medical AB:
laryngectomy
larynx cancer

ClinicalTrials.gov processed this record on August 26, 2014