Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice Prosthesis
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.
|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.|
- 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.
- 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.)
|Study Start Date:||April 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Device: Provox voice prosthesis
|Netherlands Cancer Institute|
|Amsterdam, Noord Holland, Netherlands, 1066CX|
|Principal Investigator:||Frans JM Hilgers, MD, PhD||The Netherlands Cancer Institute|
|Principal Investigator:||Michiel WM van den Brekel, MD, PhD||The Netherlands Cancer Institute|