UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035629 |
|---|---|
| Receipt number | R000040588 |
| Scientific Title | Mass production study of vaginal speculum to reduce pain |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/01/23 00:14:50 |
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Basic information
Public title
Mass production study of vaginal speculum to reduce pain
Acronym
Mass production study of vaginal speculum to reduce pain
Scientific Title
Mass production study of vaginal speculum to reduce pain
Scientific Title:Acronym
Mass production study of vaginal speculum to reduce pain
Region
| Japan |
Condition
Condition
Cervical cancer, dysplasia of cervix uteri
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
By using a new vaginal speculum in actual examination, confirm the physical safety and biological safety, and further compare the pain and discomfort felt by the patient with the conventional vaginal speculum.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain when inserting the vaginal speculum, cooling feeling
Key secondary outcomes
Physical safety and biological safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Using a prototype vaginal specimen once, quantify the pain and cooling sensation at the examination and compare both groups.
To evaluate pain, use a face scale classifying pain from 0 to 5, and cool feeling is done in 4 grades from 0 to 3 according to pain assessment.
Interventions/Control_2
Use a conventional vaginal specimen once, quantify the pain and cooling sensation at the examination, and compare both groups.
To evaluate pain, use a face scale classifying pain from 0 to 5, and cool feeling is done in 4 grades from 0 to 3 according to pain assessment.
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
| Not applicable |
Gender
Female
Key inclusion criteria
Person who is over 20 years old
Those who are judged to be able to do a diagnosis by a patient background such as past medical history
For this research, those who obtained consent by signing the consent form by the person himself / herself
Those who can answer the pain, discomfort, etc. of the diagnosis of the paratriceogram in the questionnaire
Key exclusion criteria
Study cooperation Person who did not obtain consent
Those who are supposed to have difficulty in diagnosis of gaggos such as sexual intercourse
Those who are judged not to be eligible for research participation by a doctor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohiro Kanayama |
Organization
Hamamatsu University School of Medicine
Division name
Department of obstetrics and gynecology
Zip code
Address
Higashi-ku, Hamamatsu City Hayamayama 1 - chome 20-1
TEL
0534352309
ma-ni@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mari Mukai |
Organization
Hamamatsu University School of Medicine
Division name
Department of obstetrics and gynecology
Zip code
Address
Higashi-ku, Hamamatsu City Hayamayama 1 - chome 20-1
TEL
0534352309
Homepage URL
ma-ni@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Department of obstetrics and gynecology
Institute
Department
Personal name
Funding Source
Organization
Organization for Small & Medium Enterprises and Regional Innovation, JAPAN.
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 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
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
Preinitiation
Date of protocol fixation
| 2019 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 23 | Day |
Last modified on
| 2019 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040588
