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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030970
Receipt No. R000035366
Scientific Title Comparative study of imaging diagnosis of colon polyps and cancer in colon capsule endoscopy and colonoscopy.
Date of disclosure of the study information 2018/01/25
Last modified on 2018/01/24

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

Public contact
Name of contact person
1st name
Middle name
Last name Kazuki Kakimoto
Organization Osaka Medical College
Division name The second department of internal medicine
Zip code
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
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
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 Preinitiation
Date of protocol fixation
2017 Year 11 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 26 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 01 Month 24 Day
Last modified on
2018 Year 01 Month 24 Day


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

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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