Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy (N08HME)
This study has been completed.
Sponsor:
Atos Medical AB
Collaborator:
The Netherlands Cancer Institute
Information provided by:
Atos Medical AB
ClinicalTrials.gov Identifier:
NCT00942903
First received: July 20, 2009
Last updated: October 13, 2010
Last verified: October 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Total Laryngectomy |
Device: Provox Xtra HME |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1 Study. Short-term Feasibility of the Next Generation Provox HMEs for Pulmonary Rehabilitation After Total Laryngectomy |
Resource links provided by NLM:
Further study details as provided by Atos Medical AB:
Primary Outcome Measures:
- Patient Preference for Provox HME or Provox XtraHME [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Noise at Stoma Occlusion [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]the number of patients presenting any hissing, whistling, or plopping noises before, during, or after stoma occlusion while using the new XtraHME
| Enrollment: | 20 |
| Study Start Date: | July 2009 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Compliant HME users
Laryngectomized patients who are currently compliant (24/7) users of a Provox HME
|
Device: Provox Xtra HME
Heat and Moisture Exchanger for pulmonary Rehabilitation after total laryngectomy
Other Names:
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- total laryngectomy
- compliant Provox HME user (24/7 use)
Exclusion Criteria:
- current medical problems that might influence HME use
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942903
Locations
| Netherlands | |
| Netherlands Cancer Institute | |
| Amsterdam, Noord Holland, Netherlands, 1066 CX | |
Sponsors and Collaborators
Atos Medical AB
The Netherlands Cancer Institute
Investigators
| Principal Investigator: | Frans JM Hilgers, MD | The Netherlands Cancer Institute |
More Information
No publications provided
| Responsible Party: | Corina van As-Brooks, Clinical Affairs Manager, Atos Medical |
| ClinicalTrials.gov Identifier: | NCT00942903 History of Changes |
| Other Study ID Numbers: | UD781_3CHME |
| Study First Received: | July 20, 2009 |
| Results First Received: | August 4, 2010 |
| Last Updated: | October 13, 2010 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Atos Medical AB:
|
HME Provox voice prosthesis laryngectomy |
ClinicalTrials.gov processed this record on May 19, 2013