Total Laryngectomy
Conditions
Keywords
laryngectomy, larynx cancer
Brief summary
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.
Interventions
DEVICEProvox voice prosthesis
The current voice prosthesis (Provox ActiValve)of the patients will be removed and a new prosthesis (Provox Vega) will be inserted
Sponsors
The Netherlands Cancer Institute
Atos Medical AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Total laryngectomy * Use Provox ActiValve
Exclusion criteria
* Current problems with TE puncture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short-term Feasibility Provox Vega 22.5 French | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Voice and Speech Quality | 3 weeks | 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. |
| Device Life Time | one year | 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.) |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Provox Vega 22.5 French A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Provox Vega 22.5 French |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 65.33 years STANDARD_DEVIATION 12.03 |
| Region of Enrollment Netherlands | 15 patients |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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.
Time frame: 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Provox Vega 22.5 French | Short-term Feasibility Provox Vega 22.5 French | 15 Patients |
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.)
Time frame: one year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Provox Vega 22.5 French | Device Life Time | 39.7 days | Standard Deviation 33 |
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.
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Provox Vega 22.5 French | Subjective Voice and Speech Quality | 6 units on a scale | Standard Deviation 1.5 |