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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033318
Receipt No. R000037983
Scientific Title Development of new colposcopy using laser light source
Date of disclosure of the study information 2018/09/01
Last modified on 2018/07/07

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Basic information
Public title Development of new colposcopy using laser light source
Acronym Development of new colposcopy using laser light source
Scientific Title Development of new colposcopy using laser light source
Scientific Title:Acronym Development of new colposcopy using laser light source
Region
Japan

Condition
Condition Cervical intraepithelial neoplasia
Cervical cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We aim to develop new colposcopy using laser light source and develop more accurate and universal cervical cancer diagnostic method.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes We compare image findings obtained by colposcopy with histopathological findings.
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Colposcopy with laser light source
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

Not applicable
Gender Female
Key inclusion criteria Patients who need colposcopy examination
Key exclusion criteria Patient who is difficult to take posture for more than 30 minutes on internal examination table
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimio WAKANA
Organization Tokyo Medical and Dental University Medical Hospital
Division name Department of perinatal and women's medicine
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5322
Email k.wakana.crm@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kimio WAKANA
Organization Tokyo Medical and Dental University Medical Hospital
Division name Department of perinatal and women's medicine
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5322
Homepage URL
Email k.wakana.crm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization SONY imaging products & solutions CO., LTD
Organization
Division
Category of Funding Organization Profit organization
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 東京医科歯科大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 09 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
2018 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 07 Day
Last modified on
2018 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037983

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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