Study Stopped
Primary endpoint reached, slow accrual, leakage around
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)
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 9, 2008
CompletedFirst Posted
Study publicly available on registry
April 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
November 3, 2010
CompletedMarch 10, 2017
January 1, 2017
1 year
April 9, 2008
August 2, 2010
January 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Voice Quality
at 3 months or device change (whichever was first)
Ease of Insertion
assessed immediately after insertion procedure
Reason for Replacement
At removal of prosthesis
Study Arms (1)
Early feasability arm
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- total laryngectomy
- use Provox2 voice prosthesis
- at least two prior prosthesis changes
You may not qualify if:
- current puncture problems (f. ex. infection)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Atos Medical ABlead
- The Netherlands Cancer Institutecollaborator
Study Sites (1)
Netherlands Cancer Institute
Amsterdam, North Holland, 1066CX, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Dr. F.J.M. Hilgers
- Organization
- Netherlands Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Frans JM Hilgers, MD, PhD
The Netherlands Cancer Institute
- PRINCIPAL INVESTIGATOR
Michiel WM van den Brekel, MD, PhD
The Netherlands Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2008
First Posted
April 18, 2008
Study Start
March 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
March 10, 2017
Results First Posted
November 3, 2010
Record last verified: 2017-01