UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Mass production study of vaginal speculum to reduce pain
Title of the study (Brief title)	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	Naohiro Kanayama
Organization	Hamamatsu University School of Medicine
Division name	Department of obstetrics and gynecology
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	Mari Mukai
Organization	Hamamatsu University School of Medicine
Division name	Department of obstetrics and gynecology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 03 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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