Total LaryngectomyNCT00661570
Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis
A study testing Provox Vega voice prosthesis (20 Fr) in people with Total Laryngectomy, run by Atos Medical AB at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Laryngectomy
- What is being tested?
- Provox Vega voice prosthesis (20 Fr)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- total laryngectomy
- use Provox2 voice prosthesis
- at least two prior prosthesis changes
Who cannot join
- current puncture problems (f. ex. infection)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Netherlands Cancer Institute
Amsterdam, North Holland, 1066CX
About this study
Official title: 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.
- Conditions
- Total Laryngectomy
- Being tested
- Provox Vega voice prosthesis (20 Fr)
- Keywords
- laryngectomy, larynx cancer
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provox Vega voice prosthesis (20 Fr)Device
Also called indwelling Provox voice prosthesis
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
| Study group | Role | What they receive |
|---|---|---|
| Early feasability arm | Experimental | Not described Receives: Device: Provox Vega voice prosthesis (20 Fr) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at replacement of voice prosthesis (maximum 1 year)
Secondary outcomes (3)
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.
Measured: 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.
Measured: assessed immediately after insertion procedure
Reason for Replacement
Measured: At removal of prosthesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Primary endpoint reached, slow accrual, leakage around
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Total LaryngectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atos Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Netherlands Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Frans JM Hilgers, MD, PhD, Principal investigator, The Netherlands Cancer InstituteMichiel WM van den Brekel, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661570
- Sponsor's protocol ID
- UD736
- Status last verified
- Jan 2017
- First submitted
- 9 Apr 2008
- Last updated
- 10 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)
- ClinicalTrials.gov ID
- NCT00661570
- Acronym / sponsor ID
- UD736
- Conditions
- Total Laryngectomy
- Keywords
- laryngectomy, larynx cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary endpoint reached, slow accrual, leakage around
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Atos Medical ABIndustry (pharma, biotech, devices)
- Collaborators
- The Netherlands Cancer Institute
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Posted 3 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early feasability arm | Experimental | Device: Provox Vega voice prosthesis (20 Fr) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- total laryngectomy
- use Provox2 voice prosthesis
- at least two prior prosthesis changes
Key exclusion criteria (1 listed)
- current puncture problems (f. ex. infection)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provox Vega voice prosthesis (20 Fr)Also: indwelling Provox voice prosthesisThe 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 | Device | Early feasability arm |
Primary outcome
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.
3 secondary outcomes
Voice Quality
Time frame: at 3 months or device change (whichever was first)
Ease of Insertion
Time frame: assessed immediately after insertion procedure
Reason for Replacement
Time frame: At removal of prosthesis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Total Laryngectomy
Not yet recruitingPhase 2
Early Feeding TL Trial
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A Randomized Trial Comparing Routine Use of the ActiValve to Standard Voice Prostheses
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RecruitingObservational study
Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy Patients (UC Davis)
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The Role of the Free/Pedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frans JM Hilgers, MD, PhD principal investigator
The Netherlands Cancer Institute
Michiel WM van den Brekel, MD, PhD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provox Vega voice prosthesis (20 Fr) in people with Total Laryngectomy, run by Atos Medical AB at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Life Time (time frame: at replacement of voice prosthesis (maximum 1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.