Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy

Total Laryngectomy Clinical Trial

— N08HME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00942903
• Other study ID #: UD781_3CHME
• Status: Completed
• Phase: Phase 1
• First received: July 20, 2009
• Last updated: October 13, 2010
• Start date: July 2009
• Est. completion date: August 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)Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

This study is a short term feasibility study that aims to investigate patient satisfaction with and performance of new Provox Xtra HME in 20 laryngectomized patients. Aspects that are considered are for example performance for stoma occlusion, speaking, breathing, appearance, compliance, and short-term impact on pulmonary symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• total laryngectomy

• compliant Provox HME user (24/7 use)

Exclusion Criteria:

• current medical problems that might influence HME use

Study Design

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

Related Conditions & MeSH terms

• Total Laryngectomy

Intervention

Device:
• Provox Xtra HME
Heat and Moisture Exchanger for pulmonary Rehabilitation after total laryngectomy

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	Patient Preference for Provox HME or Provox XtraHME	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.	3 weeks	No
Secondary	Noise at Stoma Occlusion	the number of patients presenting any hissing, whistling, or plopping noises before, during, or after stoma occlusion while using the new XtraHME	3 weeks	No