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 - Vega HP study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50825

Enrollment

Registered

2021-12-17

Start date

2022-01-07

Completion date

Unknown

Last updated

2026-07-13

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

Conditions

Patienten na laryngectomie met stemprothese Larynx extirpation removal of the larynx

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Laryngectomized patients using either the Provox Vega 22.5 or the Provox ActiValve Light voice prosthesis, with a length of 4, 6, 8, or 10 mm • 18 years and older

Exclusion criteria

Exclusion criteria: • Current tracheoesophageal puncture problems such as enlarged puncture or infection • Active recurrent or metastatic disease (medical deterioration) • The use of ActiValve Strong/XtraStrong or XtraSeal • Unable to understand the Patient Information and/or unable to give Informed Consent

Design outcomes

Primary

Measure	Time frame
The research concerns the advantages and limitations of the new valve design and material with respect to short term aspects such as valve stickiness, voice quality and difficulty speaking.	—

Secondary

Measure	Time frame
Stickiness of the valve, speaking effort, voice quality.	—

Countries

Netherlands

Outcome results