We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00661570
First Posted: April 18, 2008
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Netherlands Cancer Institute
Information provided by (Responsible Party):
Atos Medical AB
  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
Total Laryngectomy Device: Provox Vega voice prosthesis (20 Fr)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Atos Medical AB
ClinicalTrials.gov Identifier: NCT00661570     History of Changes
Other Study ID Numbers: UD736
First Submitted: April 9, 2008
First Posted: April 18, 2008
Results First Submitted: August 2, 2010
Results First Posted: November 3, 2010
Last Update Posted: March 10, 2017
Last Verified: January 2017

Keywords provided by Atos Medical AB:
laryngectomy
larynx cancer