UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021646 |
|---|---|
| Receipt number | R000024959 |
| Scientific Title | Smartscopy as a new device to identify the precancerous diseases of the uterine cervix |
| Date of disclosure of the study information | 2016/03/27 |
| Last modified on | 2019/05/07 20:22:57 |
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Basic information
Public title
Smartscopy as a new device to identify the precancerous diseases of the uterine cervix
Acronym
Smartscopy as a new device to identify the precancerous diseases of the uterine cervix
Scientific Title
Smartscopy as a new device to identify the precancerous diseases of the uterine cervix
Scientific Title:Acronym
Smartscopy as a new device to identify the precancerous diseases of the uterine cervix
Region
| Japan |
Condition
Condition
CIN or uterine cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a cost-effective, simple yet reliable device similar to the currently available colposcopies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
sensitivity, specificity, PPV and NPV of Smartscopy to diagnose CIN
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
We used iPhone as a new device to inspect the uterine cervix for 20 patients with abnormal cervical cytology, and named it Smartscopy. Dr. A inspected the cervix using Smartscopy, and Dr. B inspected the cervix using colposcopy for the same patient. The correlation between smartscopic abnormality and colposcopic abnormality was evaluated. The site of biopsy was determined only on the basis of the colposcopic findings.
We used Smartscopy to inspect the uterine cervix for 75 patients with abnormal cervical cytology. Dr. A inspected the cervix using Smartscopy, and Dr. B inspected the cervix using colposcopy for the same patient. The correlation between smartscopic abnormality and colposcopic abnormality was evaluated. The site of biopsy was determined on the basis of the smartscopic and colposcopic findings.
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
female patients with abnormal cervical cytology
Key exclusion criteria
none
Target sample size
95
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Ueda |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
0668793351
ZVF03563@nifty.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Ueda |
Organization
Osaka University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06687933551
Homepage URL
ZVF03563@nifty.ne.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | Month | 27 | 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
| 2015 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 27 | Day |
Last modified on
| 2019 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024959
