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Primary endpoint reached, slow accrual, leakage around
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| Name | Class |
|---|---|
| The Netherlands Cancer Institute | OTHER |
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The purpose of this study is to investigate long-term clinical feasibility of a new voice prosthesis and insertion system Provox Vega 20 with SmartInserter) for voice rehabilitation after total laryngectomy. Outcome measures are voice quality, ease of insertion, device life, and reason for replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early feasability arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provox Vega voice prosthesis (20 Fr) | Device | The current Provox2 voice prosthesis of laryngectomized patients will, when the patient comes in for a change, be replaced with a new, next generation Provox Vega voice prosthesis and insertion system |
| Measure | Description | Time Frame |
|---|---|---|
| Device Life Time | Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time. | at replacement of voice prosthesis (maximum 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Voice Quality | Subjective patient opinion about 5 voice related items (intelligibility face to face and on the phone, loudness, pitch and fluency). The best value is 5 and the worst value is 20. | at 3 months or device change (whichever was first) |
| Ease of Insertion |
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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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Patients were recruited at the outpatient clinic when they came in for a voice prosthesis replacement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Provox Vega 20 | 26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Provox Vega 20 | 26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French. |
| 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 | Device Life Time | Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time. | In 16 out of the 26 patients, the device was replaced for leakage through the device. These 16 devices were considered for calculation of device life time. | Posted | Median | Full Range | days of use | at replacement of voice prosthesis (maximum 1 year) |
|
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 20 | 26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. F.J.M. Hilgers | Netherlands Cancer Institute | +31-20-5122550 | 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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The Vega voice prosthesis used in this study is inserted with a new insertion tool, the SmartInserter. Physicians were asked to rate the insertion on a 4 point scale. what they thought of the new insertion tool, also in comparison to the regular tool used in the clinic, the Provox2 inserter. As the Provox voice prosthesis is a tool physicians already used, no insertions were performed with the Provox2 inserter during the study. |
| assessed immediately after insertion procedure |
| Reason for Replacement | At removal of prosthesis |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | patients |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Secondary | Voice Quality | Subjective patient opinion about 5 voice related items (intelligibility face to face and on the phone, loudness, pitch and fluency). The best value is 5 and the worst value is 20. | 23 patients completed the structured questionnaires about the voice prosthesis. One patient received the wrong voice prosthesis after inclusion. Two patients had unsolvable leakage around the Provox Vega 20, which is 2.5 French smaller in outer diameter than their previous Provox2 voice prosthesis. | Posted | Mean | Standard Deviation | Units on a scale | at 3 months or device change (whichever was first) |
|
|
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| Secondary | Ease of Insertion | The Vega voice prosthesis used in this study is inserted with a new insertion tool, the SmartInserter. Physicians were asked to rate the insertion on a 4 point scale. what they thought of the new insertion tool, also in comparison to the regular tool used in the clinic, the Provox2 inserter. As the Provox voice prosthesis is a tool physicians already used, no insertions were performed with the Provox2 inserter during the study. | All patients included for insertion evaluation | Posted | Number | insertions | assessed immediately after insertion procedure |
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| Secondary | Reason for Replacement | 1 patient had his Vega inappropriately removed and received a Provox2. | Posted | Number | patients | At removal of prosthesis |
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| 0 |
| 26 |
| 0 |
| 26 |
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| D007818 |
| Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |
| Title | Measurements |
|---|---|
|
| Very difficult |
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