UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027621 |
|---|---|
| Receipt number | R000031614 |
| Scientific Title | Total Observation from intestine To Anal Lesion study |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2024/12/08 10:04:43 |
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Basic information
Public title
Total Observation from intestine To Anal Lesion study
Acronym
TOTAL study
Scientific Title
Total Observation from intestine To Anal Lesion study
Scientific Title:Acronym
TOTAL study
Region
| Japan |
Condition
Condition
(suspicion of) colon diseases
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
examination of the added value of total observation from intestine to rectum using colon capsule endoscopy
Basic objectives2
Others
Basic objectives -Others
examination of efficacy and safety of colon capsule endoscopy
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
capsule endoscopic findings
Key secondary outcomes
rate of total colon observation, rate of detection of abnormal findings, receptivity of colon capsule endoscopy
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
subjects who were informed, and consented to this study.
Key exclusion criteria
diagnosed Crohn's disease, radiation colitis with stricture
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Hiraga |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Gastroenterology and hematology
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, Japan
TEL
0172-39-5053
hhiraga-gi@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Hiraga |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Gastroenterology and hematology
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, Japan
TEL
0172-39-5053
Homepage URL
hhiraga-gi@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and hematology, Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and hematology, Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Gastroenterology and hematology, Hirosaki University Graduate School of Medicine
Address
5 Zaifu-cho, Hirosaki, Japan
Tel
0172-39-5053
hhiraga-gi@umin.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
| 2017 | Year | 07 | Month | 01 | 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
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no information
Management information
Registered date
| 2017 | Year | 06 | Month | 03 | Day |
Last modified on
| 2024 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031614
