Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis

Total Laryngectomy Clinical Trial

Official title:

Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00661570
• Other study ID #: UD736
• Status: Terminated
• Phase: Phase 2
• First received: April 9, 2008
• Last updated: October 13, 2010
• Start date: March 2008
• Est. completion date: March 2009

Study information

• Verified date: October 2010
• 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 is to investigate long-term clinical feasibility of a new voice prosthesis and insertion system Provox Vega 20 with SmartInserter) for voice rehabilitation after total laryngectomy. Outcome measures are voice quality, ease of insertion, device life, and reason for replacement.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• total laryngectomy

• use Provox2 voice prosthesis

• at least two prior prosthesis changes

Exclusion Criteria:

• current puncture problems (f. ex. infection)

Study Design

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

Related Conditions & MeSH terms

• Total Laryngectomy

Intervention

Device:
• Provox Vega voice prosthesis (20 Fr)
The current Provox2 voice prosthesis of laryngectomized patients will, when the patient comes in for a change, be replaced with a new, next generation Provox Vega voice prosthesis and insertion system

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	Device Life Time	Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time.	at replacement of voice prosthesis (maximum 1 year)	No
Secondary	Voice Quality	Subjective patient opinion about 5 voice related items (intelligibility face to face and on the phone, loudness, pitch and fluency). The best value is 5 and the worst value is 20.	at 3 months or device change (whichever was first)	No
Secondary	Ease of Insertion	The Vega voice prosthesis used in this study is inserted with a new insertion tool, the SmartInserter. Physicians were asked to rate the insertion on a 4 point scale. what they thought of the new insertion tool, also in comparison to the regular tool used in the clinic, the Provox2 inserter. As the Provox voice prosthesis is a tool physicians already used, no insertions were performed with the Provox2 inserter during the study.	assessed immediately after insertion procedure	No
Secondary	Reason for Replacement		At removal of prosthesis	No