UMIN-CTR Clinical Trial

Basic information
Public title	Comparative study of imaging diagnosis of colon polyps and cancer in colon capsule endoscopy and colonoscopy.
Acronym	Diagnostic capability of colon capsule endoscopy.
Scientific Title	Comparative study of imaging diagnosis of colon polyps and cancer in colon capsule endoscopy and colonoscopy.
Scientific Title:Acronym	Diagnostic capability of colon capsule endoscopy.
Region	Japan

Condition
Condition	colon polyp
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the diagnosis capability of colon polyps and cancer in colon capsule endoscopy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The comparison of imaging diagnosis of colon polyps and cancer in colon capsule endoscopy and colonoscopy.
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	colon capsule endoscopy
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	Male and Female
Key inclusion criteria	Patients who are pointed out colon polyps or cancer by colonoscopy, and who will be treated by colonoscopy.
Key exclusion criteria	1. Suspicious Patients for gastrointestinal obstruction, stenosis, and fistula by abdominal X-ray, ultrasound and history. 2. Patients who have Crohn disease. 3. Patients with the history of chemotherapy and have gastrointestinal stenosis. 4. Patients with previous abdominal surgery and who are not to ensure the safety for colon capsule endoscopy. 5. Patients who have a cardiac pacemaker implanted or other medical electronic devices applied in the body. 6. Patients with dysphagia. 7. Patients without consent to be performed endoscopy or surgery. 8. Patients participating in other trials. 9. Patients who are judged as inappropriate by investigator.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kazuki Middle name Last name Kakimoto
Organization	Osaka Medical College
Division name	The second department of internal medicine
Zip code	5690096
Address	2-7 Daigakumachi,Takatsuki city,
TEL	072-683-1221
Email	kazuki1977924@yahoo.co.jp

Public contact
Name of contact person	1st name Kazuki Middle name Last name Kakimoto
Organization	Osaka Medical College
Division name	The second department of internal medicine
Zip code	5690096
Address	2-7 Daigakumachi,Takatsuki city,
TEL	072-683-1221
Homepage URL
Email	kazuki1977924@yahoo.co.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Self-funding
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	Osaka Medical College
Address	2-7 Daigakumachi,Takatsuki city, Osaka,Japan
Tel	072-683-1221
Email	rinri@osaka-med.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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 25 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	Open public recruiting
Date of protocol fixation	2017 Year 11 Month 19 Day
Date of IRB	2018 Year 01 Month 26 Day
Anticipated trial start date	2018 Year 01 Month 26 Day
Last follow-up date	2021 Year 07 Month 29 Day
Date of closure to data entry	2021 Year 07 Month 29 Day
Date trial data considered complete	2021 Year 07 Month 29 Day
Date analysis concluded	2021 Year 07 Month 29 Day

Other
Other related information

Management information
Registered date	2018 Year 01 Month 24 Day
Last modified on	2021 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035366