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| Name | Class |
|---|---|
| The Netherlands Cancer Institute | OTHER |
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The purpose of this study was to investigate the long-term feasibility of the new Provox Vega 22.5 voice prosthesis (outer diameter of 22.5 French) and its insertion system (SmartInserter) in laryngectomized patients who currently use a Provox2 voice prothesis.
Nowadays, many laryngectomized patients use a voice prosthesis to speak. The Provox2 is an indwelling voice prosthesis that has been on the market since 1997. Recently a new Provox voice prosthesis has been developed, the Provox Vega. This prosthesis is available in 3 different outer diameters. In this study the device with an outer diameter of 22.5 French is tested. The Provox Vega 22.5 is the successor of the Provox2 voice prosthesis. Both prostheses have an outer diameter of 22.5 French.
Outcomes were recorded by means of patient questionnaires and device life.
It is expected that some patients will like the new device (Provox Vega 22.5) better than the old one (Provox2) because the airflow resistance for speaking of the new prosthesis is lower when measured in a laboratory.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provox Vega voice prosthesis 22.5 Fr | Device | The patients' current Provox2 voice prosthesis will be removed and the new Provox Vega voice prosthesis will be inserted. |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Preference | Patients were asked "Which voice prosthesis do you prefer?" Answer options were "old one (Provox2)", "new one (Provox Vega 22.5)", or "no preference". | 3 months post insertion, or at end of device life (whichever comes sooner) |
| Measure | Description | Time Frame |
|---|---|---|
| Device Life Time | Periodic replacement of voice prostheses is considered a normal event. Over time, the device is affected by Candida which may hinder closure of the valve flap. The device life time of the voice prosthesis is determined by leakage through the device that occurs because of incomplete closure of the valve flap. At the time of analysis (6 months after placement of the devices), 25 devices had been replaced because of leakage through the device and 8 devices were still in situ. The outcomes that are reported concern the 25 devices that had been replaced. |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netherlands Cancer Institute | Amsterdam | North Holland | 1066 CX | Netherlands |
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Patients were recruited by the Netherlands Cancer Institute
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| ID | Title | Description |
|---|---|---|
| FG000 | Provox Vega 22.5 | The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Provox Vega 22.5 | The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Device Life Time | Periodic replacement of voice prostheses is considered a normal event. Over time, the device is affected by Candida which may hinder closure of the valve flap. The device life time of the voice prosthesis is determined by leakage through the device that occurs because of incomplete closure of the valve flap. At the time of analysis (6 months after placement of the devices), 25 devices had been replaced because of leakage through the device and 8 devices were still in situ. The outcomes that are reported concern the 25 devices that had been replaced. | Six months after placement of the devices, 25 out of 33 had been replaced for leakage through the device. The median device life time is based on all 33 devices. The maximum of the range reflects the 6 months cut off and not the actual maximum device life time, because of the devices still in situ at the time of analysis. | Posted | Median | Full Range | Days | 6 months |
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Adverse event data were collected for the entire period that the Provox Vega voice prosthesis was in place. Voice prostheses have a limited device life and need periodic replacement.
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 | The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Dr FJM Hilgers | Netherlands Cancer Institute | +31 20 512 2550 | f.hilgers@nki.nl |
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| 6 months |
| 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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The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5. |
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| Primary | Patient Preference | Patients were asked "Which voice prosthesis do you prefer?" Answer options were "old one (Provox2)", "new one (Provox Vega 22.5)", or "no preference". | All patients that participated in the study and finished it were analyzed | Posted | Number | Patients | 3 months post insertion, or at end of device life (whichever comes sooner) |
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| 0 |
| 33 |
| 0 |
| 33 |
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