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

Total Laryngectomy Clinical Trial

Official title:

Second Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)': Vega Siri Addendum.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743262
• Other study ID #: UD778
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2008
• Est. completion date: April 2009

Study information

• Verified date: July 2023
• Source: Atos Medical AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Total laryngectomy
• Use Provox ActiValve

Exclusion Criteria:

• Current problems with TE puncture

Related Conditions & MeSH terms

• Total Laryngectomy

Intervention

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

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute	Amsterdam	Noord Holland

Sponsors (2)

Lead Sponsor	Collaborator
Atos Medical AB	The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term Feasibility Provox Vega 22.5 French	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.	3 weeks
Secondary	Subjective Voice and Speech Quality	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.	3 weeks
Secondary	Device Life Time	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.)	one year