Long Term Use of the Provox Vega 22.5

This study has been completed.
Sponsor:
Collaborator:
The Netherlands Cancer Institute
Information provided by (Responsible Party):
Atos Medical AB
ClinicalTrials.gov Identifier:
NCT00884910
First received: April 20, 2009
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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 laryngectomized patients who currently use a Provox2 voice prothesis.


Condition Intervention Phase
Total Laryngectomy
Device: Provox Vega voice prosthesis 22.5 Fr
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Amendment on Phase 1 Trial N07VEG "Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)". Amendment 3: Long-term Use of the Provox Vega

Further study details as provided by Atos Medical AB:

Primary Outcome Measures:
  • Patient Preference [ Time Frame: 3 months post insertion, or at end of device life (whichever comes sooner) ] [ Designated as safety issue: No ]
    Patients were asked "Which voice prosthesis do you prefer?" Answer options were "old one (Provox2)", "new one (Provox Vega 22.5)", or "no preference".


Secondary Outcome Measures:
  • Device Life Time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Periodic replacement of voice prostheses is considered a normal event. Over time, the device is affected by Candida which may hinder closure of the valve flap. The device life time of the voice prosthesis is determined by leakage through the device that occurs because of incomplete closure of the valve flap. At the time of analysis (6 months after placement of the devices), 25 devices had been replaced because of leakage through the device and 8 devices were still in situ. The outcomes that are reported concern the 25 devices that had been replaced.


Enrollment: 33
Study Start Date: February 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Provox Vega voice prosthesis 22.5 Fr
    The patients' current Provox2 voice prosthesis will be removed and the new Provox Vega voice prosthesis will be inserted.
    Other Name: indwelling voice prosthesis
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 has been developed, the Provox Vega. This prosthesis is available in 3 different outer diameters. In this study the device with an outer diameter of 22.5 French is tested. The Provox Vega 22.5 is the successor of the Provox2 voice prosthesis. Both prostheses have an outer diameter of 22.5 French.

Outcomes were recorded by means of patient questionnaires and device life.

It is expected that some patients will like the new device (Provox Vega 22.5) better than the old one (Provox2) because the airflow resistance for speaking of the new prosthesis is lower when measured in a laboratory.

  Eligibility

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

Inclusion Criteria:

  • total laryngectomy
  • Provox2 user
  • at least two previous replacements

Exclusion Criteria:

  • patients' refusal
  • fistula problems
  • Provox ActiValve users
  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: NCT00884910

Locations
Netherlands
Netherlands Cancer Institute
Amsterdam, Noord Holland, Netherlands, 1066 CX
Sponsors and Collaborators
Atos Medical AB
The Netherlands Cancer Institute
Investigators
Principal Investigator: Frans JM Hilgers, MD, PhD The Netherlands Cancer Institute
  More Information

No publications provided

Responsible Party: Atos Medical AB
ClinicalTrials.gov Identifier: NCT00884910     History of Changes
Other Study ID Numbers: N07VEGA Amendment 22.5
Study First Received: April 20, 2009
Results First Received: August 2, 2010
Last Updated: July 12, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Atos Medical AB:
laryngectomy
Provox Vega
voice prosthesis

ClinicalTrials.gov processed this record on July 29, 2014