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Phase 1 Study. Short-term Feasibility of the Next Generation Provox HMEs for Pulmonary Rehabilitation After Total Laryngectomy


Phase 1
21 Years
N/A
Not Enrolling
Both
Total Laryngectomy

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Trial Information

Phase 1 Study. Short-term Feasibility of the Next Generation Provox HMEs for Pulmonary Rehabilitation After Total Laryngectomy


Inclusion Criteria:



- total laryngectomy

- compliant Provox HME user (24/7 use)

Exclusion Criteria:

- current medical problems that might influence HME use

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Preference for Provox HME or Provox XtraHME

Outcome Description:

the patient preference is based on a structured questionnaire on several aspects regarding the use of the new Provox XtraHME in comparison with the Provox HME.

Outcome Time Frame:

3 weeks

Safety Issue:

No

Principal Investigator

Frans JM Hilgers, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Netherlands Cancer Institute

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

UD781_3CHME

NCT ID:

NCT00942903

Start Date:

July 2009

Completion Date:

August 2009

Related Keywords:

  • Total Laryngectomy
  • HME
  • Provox
  • voice prosthesis
  • laryngectomy

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