Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice Prosthesis

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. Identifier: NCT00743262
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : November 3, 2010
Last Update Posted : October 6, 2016
The Netherlands Cancer Institute
Information provided by (Responsible Party):
Atos Medical AB

Brief Summary:
The purpose of this study is to investigate the performance of a new voice prosthesis in comparison with the Provox2 and the Provox ActiValve voice prosthesis in 15 laryngectomized patients. Factors taken into account are clinician and patient satisfaction with the insertion system, patient satisfaction with voice, speech, performance, and maintenance. Voice and speech will also be evaluated for the different prostheses by means of perceptual evaluations and acoustic analysis.

Condition or disease Intervention/treatment Phase
Total Laryngectomy Device: Provox voice prosthesis Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Second Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)': Vega Siri Addendum.
Study Start Date : April 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : April 2009

Intervention Details:
    Device: Provox voice prosthesis
    The current voice prosthesis (Provox ActiValve)of the patients will be removed and a new prosthesis (Provox Vega) will be inserted
    Other Name: Indwelling voice prosthesis

Primary Outcome Measures :
  1. Short-term Feasibility Provox Vega 22.5 French [ Time Frame: 3 weeks ]
    Number of participants in whom the voice prosthesis was considered feasible in the short-term with regards to clinical and technical aspects as judged by patient and investigator.

Secondary Outcome Measures :
  1. Subjective Voice and Speech Quality [ Time Frame: 3 weeks ]
    Subjective participant opinion using a structured questionnaire addressing intelligibility face to face and on the phone, loudness, pitch and fluency. Each question was measured on a four point scale. Scores were summated, best possible score is 5, worst possible score is 20.

  2. Device Life Time [ Time Frame: one year ]
    Device life time of the Provox Vega in days for replacement for leakage through the device. This is expected to be short (average about 3 weeks) since the Provox Vega 22.5 was tested in patients who normally use a Provox ActiValve. (Provox ActiValve is a problem solving prostheses used in patients who need frequent replacement of regular Provox voice prostheses short that are made of the same materials as the Provox Vega 22.5.)

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

Inclusion Criteria:

  • Total laryngectomy
  • Use Provox ActiValve

Exclusion Criteria:

  • Current problems with TE puncture

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 identifier (NCT number): NCT00743262

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

Responsible Party: Atos Medical AB Identifier: NCT00743262     History of Changes
Other Study ID Numbers: UD778
First Posted: August 28, 2008    Key Record Dates
Results First Posted: November 3, 2010
Last Update Posted: October 6, 2016
Last Verified: August 2016

Keywords provided by Atos Medical AB:
larynx cancer