Total LaryngectomyPhase 1/2NCT00743262

Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice Prosthesis

A Phase 1/2 study testing Provox voice prosthesis 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Total Laryngectomy
What is being tested?: Provox voice prosthesis
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteNetherlands
Study dates: Apr 2008to Apr 2009
Phase: Phase 1/2
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Total laryngectomy
Use Provox ActiValve

Who cannot join

Current problems with TE puncture

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Netherlands Cancer Institute
Amsterdam, North Holland, 1066CX

Other trials in Netherlands

About this study

Official title: Second Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)': Vega Siri Addendum.

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.

Conditions: Total Laryngectomy
Being tested: Provox voice prosthesis
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 voice prosthesisDevice
Also called Indwelling voice prosthesis
The current voice prosthesis (Provox ActiValve)of the patients will be removed and a new prosthesis (Provox Vega) will be inserted

Study groups in NCT00743262
Study group	Role	What they receive
Provox voice prosthesis	Experimental	Not described Receives: Device: Provox voice prosthesis

What is being measured

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

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.
Measured: 3 weeks

Secondary outcomes (2)

Subjective Voice and Speech Quality
Subjective participant opinion using a structured questionnaire addressing intelligibility face to face and on the phone, loudness, pitch and fluency. Each question was measured on a four point scale. Scores were summated, best possible score is 5, worst possible score is 20.
Measured: 3 weeks
Device Life Time
Device life time of the Provox Vega in days for replacement for leakage through the device. This is expected to be short (average about 3 weeks) since the Provox Vega 22.5 was tested in patients who normally use a Provox ActiValve. (Provox ActiValve is a problem solving prostheses used in patients who need frequent replacement of regular Provox voice prostheses short that are made of the same materials as the Provox Vega 22.5.)
Measured: one year

Timeline

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

Apr 2008Apr 2009

First posted28 Aug 2008 (estimated)
Study startApr 2008
Primary completionAug 2008
Study completionApr 2009

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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00743262
Sponsor's protocol ID: UD778
Status last verified: Jul 2023
First submitted: 15 Aug 2008
Last updated: 25 Jul 2023
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
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

All Total Laryngectomy trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Second Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)': Vega Siri Addendum.
ClinicalTrials.gov ID: NCT00743262
Acronym / sponsor ID: UD778
Conditions: Total Laryngectomy
Keywords: laryngectomy, larynx cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Atos Medical ABIndustry (pharma, biotech, devices)
Collaborators: The Netherlands Cancer Institute
Study start: Apr 2008
Primary completion: Aug 2008 (actual)
Study completion: Apr 2009 (actual)
First posted: 28 Aug 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Provox voice prosthesis	Experimental	Device: Provox voice prosthesis

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Total laryngectomy
Use Provox ActiValve

Key exclusion criteria (1 listed)

Current problems with TE puncture

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 voice prosthesisAlso: Indwelling voice prosthesisThe current voice prosthesis (Provox ActiValve)of the patients will be removed and a new prosthesis (Provox Vega) will be inserted	Device	Provox voice prosthesis

Primary outcome

Short-term Feasibility Provox Vega 22.5 French
Time frame: 3 weeks
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.

2 secondary outcomes

Subjective Voice and Speech Quality
Time frame: 3 weeks
Device Life Time
Time frame: one year

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 French	15	15

Primary outcome: Short-term Feasibility Provox Vega 22.5 French

Time frame: 3 weeks. Number. Unit: Patients

Measure	Provox Vega 22.5 French n = 15
Value	15

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were recorded from the time the new Vega prosthesis was inserted until the voice prosthesis was replaced. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Provox Vega 22.5 French	0 of 15 (0%)	0 of 15 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
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

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 Phase 1/2 study testing Provox voice prosthesis 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 2 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: finished, as of the sponsor's last update on 25 Jul 2023. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Short-term Feasibility Provox Vega 22.5 French (time frame: 3 weeks). 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 NCT00743262.

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 25 Jul 2023.