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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040588