Early clinical feasibility study of a new voice prosthesis: the Provox Vega HP

Early clinical feasibility study of a new voice prosthesis: the Provox Vega HP - Provox Vega HP study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38672

Enrollment

Registered

2013-09-04

Start date

2013-10-18

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

'total laryngectomy' 'voice rehabilitation'

Interventions

Use of the Provox Vega HP 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 6 months.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Laryngectomized patients using either the Provox Vega or the Provox ActiValve Light voice prosthesis, with a length of 6, 8, or 10 mm Age: 18 years or older

Exclusion criteria

Exclusion criteria: -Current tracheoesophageal puncture problems such as enlarged puncture or infection -Active recurrent or metastatic disease (medical deterioration) -Unable to understand the patient information and/or unable to give informed consent

Design outcomes

Primary

Measure	Time frame
The design of the study is in line with the early nature of the investigation and is observational. There are no specific outcome measures or endpoints. The investigation will cover the advantages and limitations of the new valve flap design and material related to short-term aspects such as noise of VP, bloating issues, leakage, inadvertent opening of the valve (i.e. leakage), and stickiness of the valve, voice and speech quality, speaking effort, and possible effects on voice prosthesis cleaning procedures, frequency and effectiveness of cleaning.	—

Measure

Time frame

The design of the study is in line with the early nature of the investigation and is observational. There are no specific outcome measures or endpoints. The investigation will cover the advantages and limitations of the new valve flap design and material related to short-term aspects such as noise of VP, bloating issues, leakage, inadvertent opening of the valve (i.e. leakage), and stickiness of the valve, voice and speech quality, speaking effort, and possible effects on voice prosthesis cleaning procedures, frequency and effectiveness of cleaning.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)