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

This study has been completed.
Sponsor:
Collaborator:
The Netherlands Cancer Institute
Information provided by:
Atos Medical AB
ClinicalTrials.gov Identifier:
NCT00743262
First received: August 15, 2008
Last updated: October 13, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Total Laryngectomy
Device: Provox voice prosthesis
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Atos Medical AB:

Primary Outcome Measures:
  • Short-term Feasibility Provox Vega 22.5 French [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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:
  • Subjective Voice and Speech Quality [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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.

  • Device Life Time [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.)


Enrollment: 15
Study Start Date: April 2008
Study Completion Date: April 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
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
  Eligibility

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

Inclusion Criteria:

  • Total laryngectomy
  • Use Provox ActiValve

Exclusion Criteria:

  • Current problems with TE puncture
  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: NCT00743262

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: NCT00743262     History of Changes
Other Study ID Numbers: UD778
Study First Received: August 15, 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 20, 2014