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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035629
Receipt No. 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

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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
Obsterics 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
Email 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
Email ma-ni@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Department of obstetrics and gynecology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040588

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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