- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00942903
Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy (N08HME)
October 13, 2010 updated by: Atos Medical AB
Phase 1 Study. Short-term Feasibility of the Next Generation Provox HMEs for Pulmonary Rehabilitation After Total Laryngectomy
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Noord Holland
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Amsterdam, Noord Holland, Netherlands, 1066 CX
- Netherlands Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- total laryngectomy
- compliant Provox HME user (24/7 use)
Exclusion Criteria:
- current medical problems that might influence HME use
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Compliant HME users
Laryngectomized patients who are currently compliant (24/7) users of a Provox HME
|
Heat and Moisture Exchanger for pulmonary Rehabilitation after total laryngectomy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Preference for Provox HME or Provox XtraHME
Time Frame: 3 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Noise at Stoma Occlusion
Time Frame: 3 weeks
|
the number of patients presenting any hissing, whistling, or plopping noises before, during, or after stoma occlusion while using the new XtraHME
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Frans JM Hilgers, MD, The Netherlands Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (ACTUAL)
August 1, 2009
Study Completion (ACTUAL)
August 1, 2009
Study Registration Dates
First Submitted
July 20, 2009
First Submitted That Met QC Criteria
July 20, 2009
First Posted (ESTIMATE)
July 21, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
October 22, 2010
Last Update Submitted That Met QC Criteria
October 13, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UD781_3CHME
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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