Spots Global Cancer Trial Database for Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis
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Trial Identification
Brief Title: Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis
Official Title: Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)
Study ID: NCT00661570
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to investigate long-term clinical feasibility of a new voice prosthesis and insertion system Provox Vega 20 with SmartInserter) for voice rehabilitation after total laryngectomy. Outcome measures are voice quality, ease of insertion, device life, and reason for replacement.
Detailed Description:
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Netherlands Cancer Institute, Amsterdam, Noord-Holland, Netherlands
Contact Details
Name: Frans JM Hilgers, MD, PhD
Affiliation: The Netherlands Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Michiel WM van den Brekel, MD, PhD
Affiliation: The Netherlands Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
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