Trials / Completed
CompletedNCT05079386
Clinical Feasibility of a New Voice Prosthesis
Early Clinical Feasibility Study of a New Voice Prosthesis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Atos Medical AB · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this clinical investigation is to evaluate the short-term clinical feasibility of a new voice prosthesis and explore its acceptability, limitations and advantages. As a result of the evaluations, design changes may be implemented and evaluated until the optimal design has been determined, or until it is decided not to pursue further development of the device. Main outcome will be the patient's acceptance of the voice prosthesis, secondary outcomes are stickiness of the valve mechanism and speech.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | New Voice Prosthesis | Replacement of the current prosthesis with the experimental device and use the New Voice Prosthesis for the duration of two weeks with the option of leaving the device in situ until replaced for device failure or other reason, with a maximum of 12 months. |
Timeline
- Start date
- 2022-01-07
- Primary completion
- 2023-01-27
- Completion
- 2023-01-27
- First posted
- 2021-10-15
- Last updated
- 2023-09-13
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05079386. Inclusion in this directory is not an endorsement.