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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Results First Received: August 4, 2010
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Total Laryngectomy |
| Intervention: |
Device: Provox Xtra HME |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Provox XtraHME | A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks |
Participant Flow: Overall Study
| Provox XtraHME | |
|---|---|
| STARTED | 20 |
| COMPLETED | 20 |
| NOT COMPLETED | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Provox XtraHME | A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks |
Baseline Measures
| Provox XtraHME | |
|---|---|
|
Number of Participants
[units: participants] |
20 |
|
Age
[units: patients] |
|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 10 |
|
Age
[units: years] Mean ± Standard Deviation |
66.4 ± 9.07 |
|
Gender
[units: patients] |
|
| Female | 2 |
| Male | 18 |
|
Region of Enrollment
[units: patients] |
|
| Netherlands | 20 |
Outcome Measures
| 1. Primary: | Patient Preference for Provox HME or Provox XtraHME [ Time Frame: 3 weeks ] |
| 2. Secondary: | Noise at Stoma Occlusion [ Time Frame: 3 weeks ] |
Hide Outcome Measure 2| Measure Type | Secondary |
|---|---|
| Measure Title | Noise at Stoma Occlusion |
| Measure Description | the number of patients presenting any hissing, whistling, or plopping noises before, during, or after stoma occlusion while using the new XtraHME |
| Time Frame | 3 weeks |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Provox XtraHME | A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks |
Measured Values
| Provox XtraHME | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
20 |
|
Noise at Stoma Occlusion
[units: patients] |
|
| No noise at stoma occlusion | 20 |
| Noise at stoma occlusion | 0 |
No statistical analysis provided for Noise at Stoma Occlusion
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Prof. Dr. F.J.M. Hilgers
Organization: The Netherlands Cancer Institute
phone: +31-20-5122550
e-mail: f.hilgers@nki.nl
Organization: The Netherlands Cancer Institute
phone: +31-20-5122550
e-mail: f.hilgers@nki.nl
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) |