UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027357 |
|---|---|
| Receipt number | R000031334 |
| Scientific Title | Prospective study for efficacy and safety of capsule endoscopy in children |
| Date of disclosure of the study information | 2017/05/16 |
| Last modified on | 2017/05/16 11:49:51 |
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Basic information
Public title
Prospective study for efficacy and safety of capsule endoscopy in children
Acronym
Prospective study for pediatric capsule endoscopy
Scientific Title
Prospective study for efficacy and safety of capsule endoscopy in children
Scientific Title:Acronym
Prospective study for pediatric capsule endoscopy
Region
| Japan |
Condition
Condition
Small bowel diseases
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the actual condition of use of capsule endoscopes in children in Japan, and to study its usefulness and safety prospectively in multiple facilities.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total small intestine observation rate
Key secondary outcomes
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
| 0 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Among Inpatients or outpatients in the hospitals which participate this study, patients who are suspected to have small bowel disease or have known small intestinal diseases, and who will receive capsule endoscopy.
1. Patients younger than 18 years at the time of consent
2. Patients with their or their legal representative's written consent under the free will and sufficient understanding after receiving enough explanation for the participation in this study
Key exclusion criteria
1. Abdominal X-ray examination, abdominal ultrasound examination, history of history, surgical history, clinical findings or other information sugest gastrointestinal obstruction or fistulas.
2. A patient with obvious intestinal stenosis which is expected to cause capsule retention.
3. A patient in which a cardiac pacemaker or other electro-medical device is implanted.
4. A patient with a history of barium-sulfate-induced allergy (for the patients who will recieve patency capsule.
5. patients whom research director or research collaborator judged inappropriate as subjects
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Sogo |
Organization
Saiseikai Yokohama City Tobu Hospital
Division name
Department of Pediatric Hepatology and Gastroenterology
Zip code
Address
3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa, Japan
TEL
045-576-3000
t_sogo@tobu.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Sogo |
Organization
Saiseikai Yokohama City Tobu Hospital
Division name
Department of Pediatric Hepatology and Gastroenterology
Zip code
Address
3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa, Japan
TEL
045-576-3000
Homepage URL
t_sogo@tobu.saiseikai.or.jp
Sponsor or person
Institute
Saiseikai Yokohama City Tobu Hospital
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
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
| 2017 | Year | 05 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. age, sex, height, body mass index (BMI), history of abdominal surgery
2. purpose of capsule endoscopy (CE)
3. Gastrointestinal endoscopy before CE
4. Balloon asisted enteroscopy
5. Diagnosis before CE and final diagnosis
6. Results of capsule endoscopy
7. Capability of swallowing capsule endoscopy, time for swallowing CE or patency capsule
8. Methods for preperation
9. Intervention after starting CE
10. Grade of bowel cleansing
11. contribution of CE
12. Usage og real time viewer
13. Methods for introducing CE (in cases that patients cannot swallow CE)
14. Time for introducing CE (in cases that patients cannot swallow CE)
15. Outcome and CE retention
16. Adverse events
17. Serum citrulline level
18. serum prealbumin level
19. serum transferrin level
20. serum and urin uric acid and creatinine level, and urinary specific gravity
21. Lewis Score
Management information
Registered date
| 2017 | Year | 05 | Month | 16 | Day |
Last modified on
| 2017 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031334
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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