Total LaryngectomyPhase 2NCT00884910

Long Term Use of the Provox Vega 22.5

A Phase 2 study testing Provox Vega voice prosthesis 22.5 Fr in people with Total Laryngectomy, run by Atos Medical AB at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to investigate the long-term feasibility of the new Provox Vega 22.5 voice prosthesis (outer diameter of 22.5 French) and its insertion system (SmartInserter) in laryngectomized patients who currently use a Provox2 voice prothesis. 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 22.5 Fr
Type of treatment: Medical device
How many people: 33 participants
Where: 1 siteNetherlands
Study dates: Feb 2008to Mar 2010
Phase: Phase 2
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
Provox2 user
at least two previous replacements

Who cannot join

patients' refusal
fistula problems
Provox ActiValve users

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Netherlands Cancer Institute
Amsterdam, North Holland, 1066 CX

Other trials in Netherlands

About this study

Official title: Amendment on Phase 1 Trial N07VEG "Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)". Amendment 3: Long-term Use of the Provox Vega

Read the detailed description

Nowadays, many laryngectomized patients use a voice prosthesis to speak. The Provox2 is an indwelling voice prosthesis that has been on the market since 1997. Recently a new Provox voice prosthesis has been developed, the Provox Vega. This prosthesis is available in 3 different outer diameters. In this study the device with an outer diameter of 22.5 French is tested. The Provox Vega 22.5 is the successor of the Provox2 voice prosthesis. Both prostheses have an outer diameter of 22.5 French.

Outcomes were recorded by means of patient questionnaires and device life.

It is expected that some patients will like the new device (Provox Vega 22.5) better than the old one (Provox2) because the airflow resistance for speaking of the new prosthesis is lower when measured in a laboratory.

Conditions: Total Laryngectomy
Being tested: Provox Vega voice prosthesis 22.5 Fr
Keywords: laryngectomy, Provox Vega, voice prosthesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Provox Vega voice prosthesis 22.5 FrDevice
Also called indwelling voice prosthesis
The patients' current Provox2 voice prosthesis will be removed and the new Provox Vega voice prosthesis will be inserted.

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient Preference
Patients were asked "Which voice prosthesis do you prefer?" Answer options were "old one (Provox2)", "new one (Provox Vega 22.5)", or "no preference".
Measured: 3 months post insertion, or at end of device life (whichever comes sooner)

Secondary outcomes (1)

Device Life Time
Periodic replacement of voice prostheses is considered a normal event. Over time, the device is affected by Candida which may hinder closure of the valve flap. The device life time of the voice prosthesis is determined by leakage through the device that occurs because of incomplete closure of the valve flap. At the time of analysis (6 months after placement of the devices), 25 devices had been replaced because of leakage through the device and 8 devices were still in situ. The outcomes that are reported concern the 25 devices that had been replaced.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Mar 2010

First posted21 Apr 2009 (estimated)
Study startFeb 2008
Primary completionMar 2010
Study completionMar 2010

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 2
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00884910
Sponsor's protocol ID: N07VEGA Amendment 22.5
Status last verified: Jul 2012
First submitted: 20 Apr 2009
Last updated: 16 Jul 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Early Feeding TL Trial
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Recruiting
Post-operative Use of New Adhesive After Total Laryngectomy
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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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RecruitingObservational study
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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All Total Laryngectomy trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Amendment on Phase 1 Trial N07VEG "Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)". Amendment 3: Long-term Use of the Provox Vega
ClinicalTrials.gov ID: NCT00884910
Acronym / sponsor ID: N07VEGA Amendment 22.5
Conditions: Total Laryngectomy
Keywords: laryngectomy, Provox Vega, voice prosthesis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Atos Medical ABIndustry (pharma, biotech, devices)
Collaborators: The Netherlands Cancer Institute
Study start: Feb 2008
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 21 Apr 2009 (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.

Detailed description

Outcomes were recorded by means of patient questionnaires and device life.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

total laryngectomy
Provox2 user
at least two previous replacements

Key exclusion criteria (3 listed)

patients' refusal
fistula problems
Provox ActiValve users

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 22.5 FrAlso: indwelling voice prosthesisThe patients' current Provox2 voice prosthesis will be removed and the new Provox Vega voice prosthesis will be inserted.	Device	–

Primary outcome

Patient Preference
Time frame: 3 months post insertion, or at end of device life (whichever comes sooner)
Patients were asked "Which voice prosthesis do you prefer?" Answer options were "old one (Provox2)", "new one (Provox Vega 22.5)", or "no preference".

1 secondary outcome

Device Life Time
Time frame: 6 months

Results and safety

Results posted to the registry on 3 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Provox Vega 22.5	33	32

Primary outcome: Patient Preference

Time frame: 3 months post insertion, or at end of device life (whichever comes sooner). Number. Unit: Patients

Measure	Provox Vega 22.5 n = 32
Provox Vega 22.5	14
Provox2	7
No preference	11

Population analysed: All patients that participated in the study and finished it were analyzed

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected for the entire period that the Provox Vega voice prosthesis was in place. Voice prostheses have a limited device life and need periodic replacement.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Provox Vega 22.5	0 of 33 (0%)	0 of 33 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Total Laryngectomy

Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Recruiting
Post-operative Use of New Adhesive After Total Laryngectomy
Laryngectomy
Not yet recruiting
A Randomized Trial Comparing Routine Use of the ActiValve to Standard Voice Prostheses
Laryngectomy
RecruitingObservational study
Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy Patients (UC Davis)
Speech Disorders, Speech Dysfunction
RecruitingObservational study
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)
Larynx Carcinoma

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Provox Vega voice prosthesis 22.5 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 3 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: finished, as of the sponsor's last update on 16 Jul 2012. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Patient Preference (time frame: 3 months post insertion, or at end of device life (whichever comes sooner)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00884910.

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 16 Jul 2012.