Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Device Life Time

Outcome Description:

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.

Outcome Time Frame:

at replacement of voice prosthesis (maximum 1 year)

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:

UD736

NCT ID:

NCT00661570

Start Date:

March 2008

Completion Date:

March 2009

Related Keywords:

• Total Laryngectomy
• laryngectomy
• larynx cancer