Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis
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|ClinicalTrials.gov Identifier: NCT00661570|
Recruitment Status : Terminated (Primary endpoint reached, slow accrual, leakage around)
First Posted : April 18, 2008
Results First Posted : November 3, 2010
Last Update Posted : March 10, 2017
|Condition or disease||Intervention/treatment|
|Total Laryngectomy||Device: Provox Vega voice prosthesis (20 Fr)|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)|
|Study Start Date :||March 2008|
|Primary Completion Date :||March 2009|
|Study Completion Date :||March 2009|
|Experimental: Early feasability arm||
Device: Provox Vega voice prosthesis (20 Fr)
The current Provox2 voice prosthesis of laryngectomized patients will, when the patient comes in for a change, be replaced with a new, next generation Provox Vega voice prosthesis and insertion system
Other Name: indwelling Provox voice prosthesis
- Device Life Time [ Time Frame: at replacement of voice prosthesis (maximum 1 year) ]Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time.
- Voice Quality [ Time Frame: at 3 months or device change (whichever was first) ]Subjective patient opinion about 5 voice related items (intelligibility face to face and on the phone, loudness, pitch and fluency). The best value is 5 and the worst value is 20.
- Ease of Insertion [ Time Frame: assessed immediately after insertion procedure ]The Vega voice prosthesis used in this study is inserted with a new insertion tool, the SmartInserter. Physicians were asked to rate the insertion on a 4 point scale. what they thought of the new insertion tool, also in comparison to the regular tool used in the clinic, the Provox2 inserter. As the Provox voice prosthesis is a tool physicians already used, no insertions were performed with the Provox2 inserter during the study.
- Reason for Replacement [ Time Frame: At removal of prosthesis ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661570
|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|