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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027357
Receipt No. 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

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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
Email 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
Email t_sogo@tobu.saiseikai.or.jp

Sponsor
Institute Saiseikai Yokohama City Tobu Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031334

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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