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

Atos Medical AB1 site in 1 country26 target enrollmentMarch 2008

ConditionsTotal Laryngectomy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Total Laryngectomy
Sponsor: Atos Medical AB
Enrollment: 26
Locations: 1
Primary Endpoint: Device Life Time
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

March 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Atos Medical AB

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•total laryngectomy
•use Provox2 voice prosthesis
•at least two prior prosthesis changes

Exclusion Criteria

•current puncture problems (f. ex. infection)

Outcomes

Primary Outcomes

Device Life Time

Time Frame: at replacement of voice prosthesis (maximum 1 year)

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.