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

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

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.

Study Overview

• Status: Terminated
• Conditions: Total Laryngectomy
• Intervention / Treatment: Device: Provox Vega voice prosthesis (20 Fr)

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1066CX
      • Netherlands Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• current puncture problems (f. ex. infection)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: indwelling Provox voice prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Life Time	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.	at replacement of voice prosthesis (maximum 1 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voice Quality	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.	at 3 months or device change (whichever was first)
Ease of Insertion	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.	assessed immediately after insertion procedure
Reason for Replacement		At removal of prosthesis

Collaborators and Investigators

• Sponsor: Atos Medical AB
• Collaborators: The Netherlands Cancer Institute
• Investigators: Principal Investigator: Michiel WM van den Brekel, MD, PhD, The Netherlands Cancer Institute

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (ACTUAL): March 1, 2009
• Study Completion (ACTUAL): March 1, 2009

Study Registration Dates

• First Submitted: April 9, 2008
• First Submitted That Met QC Criteria: April 17, 2008
• First Posted (ESTIMATE): April 18, 2008

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: laryngectomy; larynx cancer
• Other Study ID Numbers: UD736