Long Term Use of the Provox Vega 22.5

Total Laryngectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884910
• Other study ID #: N07VEGA Amendment 22.5
• Status: Completed
• Phase: Phase 2
• First received: April 20, 2009
• Last updated: July 12, 2012
• Start date: February 2008
• Est. completion date: March 2010

Study information

• Verified date: July 2012
• Source: Atos Medical AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to investigate the long-term feasibility of the new Provox Vega 22.5 voice prosthesis (outer diameter of 22.5 French) and its insertion system (SmartInserter) in laryngectomized patients who currently use a Provox2 voice prothesis.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• total laryngectomy

• Provox2 user

• at least two previous replacements

Exclusion Criteria:

• patients' refusal

• fistula problems

• Provox ActiValve users

Study Design

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

Related Conditions & MeSH terms

• Total Laryngectomy

Intervention

Device:
• Provox Vega voice prosthesis 22.5 Fr
The patients' current Provox2 voice prosthesis will be removed and the new Provox Vega voice prosthesis will be inserted.

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute	Amsterdam	Noord Holland

Sponsors (2)

Lead Sponsor	Collaborator
Atos Medical AB	The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Preference	Patients were asked "Which voice prosthesis do you prefer?" Answer options were "old one (Provox2)", "new one (Provox Vega 22.5)", or "no preference".	3 months post insertion, or at end of device life (whichever comes sooner)	No
Secondary	Device Life Time	Periodic replacement of voice prostheses is considered a normal event. Over time, the device is affected by Candida which may hinder closure of the valve flap. The device life time of the voice prosthesis is determined by leakage through the device that occurs because of incomplete closure of the valve flap. At the time of analysis (6 months after placement of the devices), 25 devices had been replaced because of leakage through the device and 8 devices were still in situ. The outcomes that are reported concern the 25 devices that had been replaced.	6 months	No