Laryngectomy; StatusNCT05482815
Evaluation of the Safety and Efficacy of Voice Prosthesis in Voice Reconstruction After Total Laryngectomy
A study testing Provox Vega Voice prosthesis in people with Laryngectomy; Status, run by Atos Medical AB at 3 sites in China.
Trial summary
The objective of the study is to evaluate the clinical safety and efficacy of voice prosthesis for voice reconstruction after total laryngectomy in China. Main outcome will be the assessment of pronunciation effect (subjective auditory assessment). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngectomy; Status
- What is being tested?
- Provox Vega Voice prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesChina
- Study dates
- 5 May 2021to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- The age is greater than 18 years; the gender is not limited
- Performed total laryngectomy;
- No voice prosthesis has been installed
- Be able to take care of themselves mentally and physically, and have good hand coordination ability
- With healthy wall sharing with trachea and esophagus
- The patient has a desire to restore articulation function
- Can speak Mandarin and have a certain reading ability (equivalent to primary school education)
- The subject is fully aware of the benefits and risks of this trial and is willing to participate in and sign the informed consent form
Who cannot join
- There is serious respiratory system disease or defect
- There is a serious skin disease in the tracheostoma
- Obvious intelligence and mental disorder
- Tracheostoma is narrow and needs cannula implantation
- Patients with limitation of mouth opening and other subjects with dyslalia or language disorders (such as subjects with sequelae of cerebral infarction, etc.)
- Patients with severe respiratory disease, cardiopulmonary disease (e.g., severe arrhythmia, persons with slow ventricular rate (ventricular rate <50 beats/ min), acute phase of myocardial infarction and severe heart failure), disturbances of blood coagulation (coagulation index PT, APTT, INR> 1.5 times of the normal upper limit), septicemia and other patients not suitable
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- Patients with severe diseases of liver and renal function (liver function index, alanine aminotransferase (ALT), aspartate aminotransferase (AST)> 2 times of normal upper limit, renal function index, urine creatinine (Cr), blood urea nitrogen (BUN)> 2 times of normal upper limit);
- Patients with local recurrence of tumor or metastatic tumor
- If the patient has received esophageal articulation training, the time of training and using esophagus to speech should be less than 6 months
- Women planning to have child, in lactation or pregnancy during the whole clinical study
- Participated in other clinical trials within 1 month
- Other candidates the investigators think not appropriate
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Tongren Hospital, CMU
Beijing
Peking Union Medical College Hospital
Beijing
Eye & ENT Hospital of Fudan University
Shanghai
About this study
Official title: Evaluation of the Safety and Efficacy of Voice Prosthesis in Voice Reconstruction After Total Laryngectomy: a Prospective, Multicenter, Self-controlled Clinical Trial
The objective of the study is to evaluate the clinical safety and efficacy of voice prosthesis for voice reconstruction after total laryngectomy in China.
Main outcome will be the assessment of pronunciation effect (subjective auditory assessment).
- Conditions
- Laryngectomy; Status
- Being tested
- Provox Vega Voice prosthesis
- Keywords
- Voice rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provox Vega Voice prosthesisDevice
Voice prosthesis for speech rehabilitation, Provox Vega Voice prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Voice Prosthesis | Experimental | Subjects receive a Voice prosthesis using the Provox Puncture Set, then undergo an articulation training program (3 weeks). The voice prosthesis is replaced after 3 months and 6 months. Receives: Device: Provox Vega Voice prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pronunciation effect (subjective auditory assessment)
Voice recordings judged by two independent evaluators, scored from 1-7, with lower scores meaning worse speech.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (7)
Change in longest articulation time (continuous /a/, count)
The longest duration time of one continuous / a / is recorded by a stopwatch, count and the average of three times are taken at the same time.
Measured: Baseline, 3 months, 6 months
Change in sound intensity (minimum / maximum / comfortable);
Sound intensity of the minimum / maximum / comfortable loudness (measured 3 times per person) is recorded to calculate the dynamic range (in decibels)
Measured: Baseline, 3 months, 6 months
Change in total time required to read a text
Standard Chinese text is read out loud, and the total time is recorded.
Measured: Baseline, 3 months, 6 months
Change in Voice Handicap Index
Validated tool to assess Voice handicap. Statements on participant's voice quality and effect on social life are assessed by a five-point Likert-scale, ranged from 0-4, with high scores indicating more handicap (0 = Never, 4 = Always).
Measured: Baseline, 3 months, 6 months
Change in Quality of Life by SF-36
Patient reported, 36-item, Score of calculated, ranging from 0-100, the lower the score the more disability. The higher the score the less disability
Measured: Baseline, 3 months, 6 months
Evaluation of operative performance
Study-specific questionnaire on feasibility and satisfaction of clinicians
Measured: Baseline, 3 months, 6 months
Incidence of Adverse Events
Any adverse events (including serious adverse events and device defect rates) will be recorded.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start5 May 2021
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngectomy; StatusStudies 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
- Model description
- prospective, multicenter, single-group test target trial design
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atos Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital, Beijing Tongren Hospital, Eye & ENT Hospital of Fudan University
- Responsible party
- Sponsor
- Investigators
- Gao Zhiqiang, Chief Physician, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482815
- Sponsor's protocol ID
- AMAB-FYN-1.0
- Status last verified
- Sep 2023
- First submitted
- 26 Jul 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Voice Prosthesis in Voice Reconstruction After Total Laryngectomy: a Prospective, Multicenter, Self-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05482815
- Acronym / sponsor ID
- AMAB-FYN-1.0
- Conditions
- Laryngectomy; Status
- Keywords
- Voice rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Atos Medical ABIndustry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital, Beijing Tongren Hospital, Eye & ENT Hospital of Fudan University
- Study start
- 5 May 2021 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the clinical safety and efficacy of voice prosthesis for voice reconstruction after total laryngectomy in China.
Main outcome will be the assessment of pronunciation effect (subjective auditory assessment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, multicenter, single-group test target trial design
| Arm | Type | Receives |
|---|---|---|
| Voice Prosthesis | Experimental | Device: Provox Vega Voice prosthesisSubjects receive a Voice prosthesis using the Provox Puncture Set, then undergo an articulation training program (3 weeks). The voice prosthesis is replaced after 3 months and 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The age is greater than 18 years; the gender is not limited
- Performed total laryngectomy;
- No voice prosthesis has been installed
- Be able to take care of themselves mentally and physically, and have good hand coordination ability
- With healthy wall sharing with trachea and esophagus
Key exclusion criteria (12 listed)
- There is serious respiratory system disease or defect
- There is a serious skin disease in the tracheostoma
- Obvious intelligence and mental disorder
- Tracheostoma is narrow and needs cannula implantation
- Patients with limitation of mouth opening and other subjects with dyslalia or language disorders (such as subjects with sequelae of cerebral infarction, etc.)
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 prosthesisVoice prosthesis for speech rehabilitation, Provox Vega Voice prosthesis | Device | Voice Prosthesis |
Primary outcome
Change in pronunciation effect (subjective auditory assessment)
Time frame: Baseline, 3 months, 6 months
Voice recordings judged by two independent evaluators, scored from 1-7, with lower scores meaning worse speech.
7 secondary outcomes
Change in longest articulation time (continuous /a/, count)
Time frame: Baseline, 3 months, 6 months
Change in sound intensity (minimum / maximum / comfortable);
Time frame: Baseline, 3 months, 6 months
Change in total time required to read a text
Time frame: Baseline, 3 months, 6 months
Change in Voice Handicap Index
Time frame: Baseline, 3 months, 6 months
Change in Quality of Life by SF-36
Time frame: Baseline, 3 months, 6 months
Evaluation of operative performance
Time frame: Baseline, 3 months, 6 months
Incidence of Adverse Events
Time frame: Baseline, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Laryngectomy; Status
RecruitingObservational study
Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy Patients (UC Davis)
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Workshops and Exchange Groups for Laryngectomized Patients
Laryngectomy; Status, Laryngeal Cancer
RecruitingPhase 2
European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]
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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.
Gao Zhiqiang, Chief Physician principal investigator
Peking Union Medical College Hospital
3 sites 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 in people with Laryngectomy; Status, run by Atos Medical AB at 3 sites in China.
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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
Results are not available in the source record.
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?
Change in pronunciation effect (subjective auditory assessment) (time frame: Baseline, 3 months, 6 months). 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 13 Sep 2023.