An interventional study of Provox Vega voice prosthesis (20 Fr) in Total Laryngectomy, sponsored by Atos Medical AB. Terminated at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2017-03-10.
Sponsored by Atos Medical AB (part of Coloplast A/S) · Not applicable, Interventional, and Treatment
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.
248 studies on the registry are indexed under Laryngeal Neoplasms; 64 are open to participants now.
This study's enrollment of 26 is below the median of 44 across 184 interventional studies indexed under Laryngeal Neoplasms.
Browse Laryngeal Neoplasms studies →Atos Medical AB is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
First submitted before Atos Medical AB became part of Coloplast A/S.
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Exclusion Criteria:
Device: Provox Vega voice prosthesis (20 Fr)
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
Also known as: indwelling Provox voice prosthesis
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.
Time frame: at replacement of voice prosthesis (maximum 1 year)
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.
Time frame: at 3 months or device change (whichever was first)
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.
Time frame: assessed immediately after insertion procedure
Reason for Replacement
Time frame: At removal of prosthesis
Patients were recruited at the outpatient clinic when they came in for a voice prosthesis replacement.
| Milestone | Provox Vega 20 |
|---|---|
| Started | 26 |
| Completed | 26 |
| Not completed | 0 |
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.
| days of use | Provox Vega 20 |
|---|---|
| Device Life Time | 93 ± 81.85 |
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.
| Units on a scale | Provox Vega 20 |
|---|---|
| Voice Quality | 8.4 ± 4.4 |
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.
| insertions | Provox Vega 20 |
|---|---|
| Not difficult at all | 20 |
| A little difficult | 4 |
| Rather difficult | 1 |
| Very difficult | 1 |
| patients | Provox Vega 20 |
|---|---|
| leakage through prosthesis | 16 |
| periprosthetic leakage due to smaller diameter | 5 |
| combination of causes | 4 |
Collected over Adverse events were recorded from the time the new Vega prosthesis was inserted until the voice prosthesis was replaced.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Provox Vega 20 | — | 0/26 (0%) | 0/26 (0%) |
| Age, Categorical(Participants) | Provox Vega 20 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 14 |
| Age, Continuous(years) | Provox Vega 20 |
|---|---|
| Mean | 67.69 ± 12.18 |
| Sex: Female, Male(Participants) | Provox Vega 20 |
|---|---|
| Female | 5 |
| Male | 21 |
| Region of Enrollment(patients) | Provox Vega 20 |
|---|---|
| Netherlands | 26 |
This study is terminated, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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