UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045070 |
|---|---|
| Receipt number | R000051491 |
| Scientific Title | Examination of colon capsule endoscopy using the method of filling capsules with castor oil |
| Date of disclosure of the study information | 2021/08/05 |
| Last modified on | 2023/08/07 09:07:11 |
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Basic information
Public title
Examination of colon capsule endoscopy using the method of filling capsules with castor oil
Acronym
Examination of colon capsule endoscopy using the method of filling capsules with castor oil
Scientific Title
Examination of colon capsule endoscopy using the method of filling capsules with castor oil
Scientific Title:Acronym
Examination of colon capsule endoscopy using the method of filling capsules with castor oil
Region
| Japan |
Condition
Condition
Cases for lower gastrointestinal endoscopy that colon fiber is difficult
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To present the inspection results of CCE using castor oil, and also investigated the procedure and results of a new CCE method, the "castor oil capsule filling method", as a pilot study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Capsule excretion rate within its battery life of colon capsule endoscopy using the method of filling capsules with castor oil
Key secondary outcomes
(1) Total examination time, colon arrival time, colon observation time, total water dose, bowel irrigation degree, adverse events in colon capsule endoscopy using the method of filling capsules with castor oil
(2) Patient tolerability
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who comply with the following indication criteria for colorectal capsule endoscopy
(1) Patients who required colonoscopy and performed colon fiber scopy but could not reach the ileocecal region due to adhesions, etc.
(2) Patients who require colonoscopy but are judged to have difficulty in performing colon fiber scopy due to organic abnormalities such as adhesions.
Key exclusion criteria
Patients in which consent was not obtained for this study
Target sample size
51
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Mizukami |
Organization
Oita University
Division name
Department of Gastroenterology
Zip code
879-5593
Address
1-1, idaigaoka, Hasama, Yufu, Oita
TEL
0975866193
mizkaz0809@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Mizukami |
Organization
Oita University
Division name
Department of Gastroenterology
Zip code
879-5593
Address
1-1, idaigaoka, Hasama, Yufu, Oita
TEL
097-586-6193
Homepage URL
mizkaz0809@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
Oita University
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
Ethics Committee, Oita University
Address
1-1, idaigaoka, Hasama, Yufu, Oita
Tel
097-586-6380
rinrikenkyu@oita-u.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
| 2021 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
51
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
| 2021 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not particular
Management information
Registered date
| 2021 | Year | 08 | Month | 05 | Day |
Last modified on
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051491
