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Amendment on Phase 1 Trial N07VEG "Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)". Amendment 3: Long-term Use of the Provox Vega


Phase 2
N/A
N/A
Not Enrolling
Both
Total Laryngectomy

Thank you

Trial Information

Amendment on Phase 1 Trial N07VEG "Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)". Amendment 3: Long-term Use of the Provox Vega


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.


Inclusion Criteria:



- total laryngectomy

- Provox2 user

- at least two previous replacements

Exclusion Criteria:

- patients' refusal

- fistula problems

- Provox ActiValve users

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Patient Preference

Outcome Description:

Patients were asked "Which voice prosthesis do you prefer?" Answer options were "old one (Provox2)", "new one (Provox Vega 22.5)", or "no preference".

Outcome Time Frame:

3 months post insertion, or at end of device life (whichever comes sooner)

Safety Issue:

No

Principal Investigator

Frans JM Hilgers, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Netherlands Cancer Institute

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

N07VEGA Amendment 22.5

NCT ID:

NCT00884910

Start Date:

February 2008

Completion Date:

March 2010

Related Keywords:

  • Total Laryngectomy
  • laryngectomy
  • Provox Vega
  • voice prosthesis

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