UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037049 |
|---|---|
| Receipt number | R000042217 |
| Scientific Title | Validation test of the new penile tumescence and stiffness monitoring device |
| Date of disclosure of the study information | 2019/06/13 |
| Last modified on | 2021/03/15 19:11:27 |
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Basic information
Public title
Validation test of the new penile tumescence and stiffness monitoring device
Acronym
Validation test of the new penile tumescence and stiffness monitoring device
Scientific Title
Validation test of the new penile tumescence and stiffness monitoring device
Scientific Title:Acronym
Validation test of the new penile tumescence and stiffness monitoring device
Region
| Japan |
Condition
Condition
Erectile Dysfunction
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation test of the new penile tumescence and stiffness monitoring device
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Can the new device measure nocturnal penile tumescence?
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The new penile tumescence and stiffness monitoring device
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
Agreed to take a measurement of penile stifness using the new device (Irrepective of the presence of erectile dysfunction)
Key exclusion criteria
Patients whom the physician considered inappropriate for this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Matsumoto |
Organization
Asahikawa Medical University
Division name
Center for Advanced Research and Education
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-Higashi, Asahikawa 078-8510, Hokkaido, JAPAN
TEL
0166-68-2618
matsums@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Matsumoto |
Organization
Asahikawa Medical University
Division name
Center for Advanced Research and Education
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-Higashi, Asahikawa 078-8510, Hokkaido, JAPAN
TEL
0166-68-2618
Homepage URL
matsums@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1, Midorigaoka-Higashi, Asahikawa 078-8510, Hokkaido, JAPAN
Tel
0166-68-2187
rs-kk.g@asahikawa-med.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 13 | 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
10
Results
Results date posted
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
| 2019 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 06 | Month | 13 | Day |
Last modified on
| 2021 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042217
