UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050612 |
|---|---|
| Receipt number | R000057651 |
| Scientific Title | An Exploratory Study of the Efficacy of a heat and moisture exchanger (Provox LifeTM Home HME) in Patients with Total Laryngectomy |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/03/19 21:21:04 |
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Basic information
Public title
An Exploratory Study of the Efficacy of a heat and moisture exchanger (Provox LifeTM Home HME) in Patients with Total Laryngectomy
Acronym
An Exploratory Study of the Efficacy of a heat and moisture exchanger (Provox LifeTM Home HME) in Patients with Total Laryngectomy
Scientific Title
An Exploratory Study of the Efficacy of a heat and moisture exchanger (Provox LifeTM Home HME) in Patients with Total Laryngectomy
Scientific Title:Acronym
An Exploratory Study of the Efficacy of a heat and moisture exchanger (Provox LifeTM Home HME) in Patients with Total Laryngectomy
Region
| Japan |
Condition
Condition
After total laryngectomy
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy of Provox LifeTM Home HME for patients with total laryngectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in number of coughs per day
Key secondary outcomes
Change in color of sputum
Skin disorders
QOL
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients wear the new a heat and moisture exchanger (Provox LifeTM Home HME) and the existing a heat and moisture exchanger for 6 weeks each and complete a questionnaire about the frequency of coughing and the properties of sputum.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patients who have undergone total laryngectomy
2. 18 years of age or older
3. more than 3 months after total laryngectomy
4. more than 6 weeks after completion of postoperative radiation therapy
5. Patients who have been using a heat and moisture exchanger other than Provox LifeTM Home HME for more than 3 months.
6. Patients who are clinically judged to be eligible for Provox LifeTM Home HME.
7. Patients who have given written consent to the study
Key exclusion criteria
1.Patients who have never used a heat and moisture exchanger before the start of this study
2. Patients who cannot put on and take off a heat and moisture exchanger by themselves
3. Patients with recurrent tumor or metastatic disease
4. Patients with pulmonary infection or exacerbation of respiratory disease such as COPD within one month.
5. Patients who are unable to understand the questionnaire or consent form due to cognitive decline.
6. Patients who have changed the dosage of cough suppressants or expectorants within one month prior to entry into the study.
7. Patients with skin disorders requiring treatment at the site of a heat and moisture exchanger
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Shinomiya |
Organization
Kobe University
Division name
Department of Otorhinolaryngology-Head and Neck Surgery
Zip code
6500017
Address
7-5-2 Kusunoki-cho,Chuo-ku,Kobe-shi,Hyogo,Japan
TEL
078-382-6024
hshino@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Takeda |
Organization
Kobe University
Division name
Department of Otorhinolaryngology-Head and Neck Surgery
Zip code
6500017
Address
7-5-2 Kusunoki-cho,Chuo-ku,Kobe-shi,Hyogo,Japan
TEL
078-382-6024
Homepage URL
piyo1992@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital CTRC for client
Address
7-5-2 Kusunoki-cho,Chuo-ku,Kobe-shi,Hyogo,Japan
Tel
078-382-5400
chiken@med.kobe-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
神戸大学医学部付属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Significant decrease in the number of coughs per day. Respiratory distress significantly improved.
Results date posted
| 2024 | Year | 03 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 17 | Day |
Last modified on
| 2024 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057651
