Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice Prosthesis
Second Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)': Vega Siri Addendum.
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of this study is to investigate the performance of a new voice prosthesis in comparison with the Provox2 and the Provox ActiValve voice prosthesis in 15 laryngectomized patients. Factors taken into account are clinician and patient satisfaction with the insertion system, patient satisfaction with voice, speech, performance, and maintenance. Voice and speech will also be evaluated for the different prostheses by means of perceptual evaluations and acoustic analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 15, 2008
CompletedFirst Posted
Study publicly available on registry
August 28, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
November 3, 2010
CompletedJuly 25, 2023
July 1, 2023
4 months
August 15, 2008
August 2, 2010
July 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Short-term Feasibility Provox Vega 22.5 French
Number of participants in whom the voice prosthesis was considered feasible in the short-term with regards to clinical and technical aspects as judged by patient and investigator.
3 weeks
Secondary Outcomes (2)
Subjective Voice and Speech Quality
3 weeks
Device Life Time
one year
Study Arms (1)
Provox voice prosthesis
EXPERIMENTALInterventions
The current voice prosthesis (Provox ActiValve)of the patients will be removed and a new prosthesis (Provox Vega) will be inserted
Eligibility Criteria
You may qualify if:
- Total laryngectomy
- Use Provox ActiValve
You may not qualify if:
- Current problems with TE puncture
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)
Limitations and Caveats
Provox ActiValve users have short device life with normal indwelling prostheses (and hence use the Provox ActiValve). Therefore, the device life measured in this patient group is very short and not representative of the normal Provox Vega user.
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
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2008
First Posted
August 28, 2008
Study Start
April 1, 2008
Primary Completion
August 1, 2008
Study Completion
April 1, 2009
Last Updated
July 25, 2023
Results First Posted
November 3, 2010
Record last verified: 2023-07