UMIN-CTR Clinical Trial

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	Obsterics 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
Last 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
Email	ZVF03563@nifty.ne.jp

Public contact
1st 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
Email	ZVF03563@nifty.ne.jp

Sponsor
Institute	Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024959