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| Name | Class |
|---|---|
| The Netherlands Cancer Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Provox voice prosthesis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provox voice prosthesis | Device | The current voice prosthesis (Provox ActiValve)of the patients will be removed and a new prosthesis (Provox Vega) will be inserted |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frans JM Hilgers, MD, PhD | The Netherlands Cancer Institute | Principal Investigator |
| Michiel WM van den Brekel, MD, PhD | The Netherlands Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netherlands Cancer Institute | Amsterdam | North Holland | 1066CX | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | Provox Vega 22.5 French | A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Provox Vega 22.5 French | A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Patients | 3 weeks |
|
|
Adverse Events were recorded from the time the new Vega prosthesis was inserted until the voice prosthesis was replaced
Adverse events were assessed after the insertion procedure, upon notification of a problem by the patient, and when the Provox Vega needed replacement. Normal reasons for replacement (leakage through, size changes) were not considered adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Provox Vega 22.5 French | A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. F.J.M. Hilgers | Netherlands Cancer Institute | +31-20-5252550 | f.hilgers@nki.nl |
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| ID | Term |
|---|---|
| D007822 | Laryngeal Neoplasms |
| ID | Term |
|---|---|
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 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.) |
| one year |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | patients |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 weeks |
|
|
|
| Secondary | 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.) | Posted | Mean | Standard Deviation | days | one year |
|
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| 0 |
| 15 |
| 0 |
| 15 |
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| D007818 |
| Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |