![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000027621 |
Receipt No. | R000031614 |
Scientific Title | Total Observation from intestine To Anal Lesion study |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2017/06/03 |
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 |
|
Condition | ||
Condition | (suspicion of) colon diseases | |
Classification by specialty |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
Organization | Hirosaki University Graduate School of Medicine | ||||||
Division name | Department of Gastroenterology and hematology | ||||||
Zip code | |||||||
Address | 5 Zaifu-cho, Hirosaki, Japan | ||||||
TEL | 0172-39-5053 | ||||||
hhiraga-gi@umin.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Hirosaki University Graduate School of Medicine | ||||||
Division name | Department of Gastroenterology and hematology | ||||||
Zip code | |||||||
Address | 5 Zaifu-cho, Hirosaki, Japan | ||||||
TEL | 0172-39-5053 | ||||||
Homepage URL | |||||||
hhiraga-gi@umin.ac.jp |
Sponsor | |
Institute | Department of Gastroenterology and hematology, Hirosaki University Graduate School of Medicine |
Institute | |
Department |
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 | |
Address | |
Tel | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | no information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031614 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |