NCT00884910

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
8 months until next milestone

Results Posted

Study results publicly available

November 3, 2010

Completed
Last Updated

July 16, 2012

Status Verified

July 1, 2012

Enrollment Period

2.1 years

First QC Date

April 20, 2009

Results QC Date

August 2, 2010

Last Update Submit

July 12, 2012

Conditions

Total Laryngectomy

Keywords

laryngectomyProvox Vegavoice prosthesis

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Device Life Time

    6 months

Interventions

Provox Vega voice prosthesis 22.5 FrDEVICE

The patients' current Provox2 voice prosthesis will be removed and the new Provox Vega voice prosthesis will be inserted.

Also known as: indwelling voice prosthesis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • total laryngectomy
  • Provox2 user
  • at least two previous replacements

You may not qualify if:

  • patients' refusal
  • fistula problems
  • Provox ActiValve users

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Results Point of Contact

Title
Prof Dr FJM Hilgers
Organization
Netherlands Cancer Institute
f.hilgers@nki.nl
+31 20 512 2550

Study Officials

  • Frans JM Hilgers, MD, PhD

    The Netherlands Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 21, 2009

Study Start

February 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

July 16, 2012

Results First Posted

November 3, 2010

Record last verified: 2012-07

Locations

NL(1)