UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030970 |
|---|---|
| Receipt number | 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 | 2021/07/29 08:21:35 |
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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 | 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
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
kazuki1977924@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035366
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
