NCT00743262

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Atos Medical AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Total Laryngectomy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-08-01
• Completion: 2009-04-01
• First posted: 2008-08-28
• Last updated: 2023-07-25
• Results posted: 2010-11-03

Locations

1 site across 1 country: Netherlands