UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033318 |
|---|---|
| Receipt number | R000037983 |
| Scientific Title | Development of new colposcopy using laser light source |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2021/06/11 16:03:20 |
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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
| Obstetrics 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 | Kimio |
| Middle name | |
| Last name | WAKANA |
Organization
Tokyo Medical and Dental University Medical Hospital
Division name
Department of perinatal and women's medicine
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5322
k.wakana.crm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kimio |
| Middle name | |
| Last name | WAKANA |
Organization
Tokyo Medical and Dental University Medical Hospital
Division name
Department of perinatal and women's medicine
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5322
Homepage URL
k.wakana.crm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
Tokyo Medical and Dental University Ethics Review Committee
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-3813-6111
syomu1.adm@tmd.ac.jp
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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 07 | Day |
Last modified on
| 2021 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037983
