Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis

Not Applicable

Terminated

• Conditions: Total Laryngectomy
• Interventions: Device: Provox Vega voice prosthesis (20 Fr)

• Registration Number: NCT00661570
• Lead Sponsor: Atos Medical AB

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

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-09
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-18
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2010-08-02
• Results First Submitted QC: 2010-10-13
• Results First Posted: 2010-11-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• total laryngectomy
• use Provox2 voice prosthesis
• at least two prior prosthesis changes

Exclusion Criteria

• current puncture problems (f. ex. infection)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Early feasability arm	Provox Vega voice prosthesis (20 Fr)	-

Primary Outcome Measures

Name	Time	Method
Device Life Time	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.

Secondary Outcome Measures

Name	Time	Method
Voice Quality	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	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	At removal of prosthesis

Trial Locations

Locations (1)

Netherlands Cancer Institute; 🇳🇱 Amsterdam, Noord-Holland, Netherlands