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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037143
Receipt No. R000041222
Scientific Title Multicenter prospective registration study of efficacy and safety of capsule endoscopy in Crohn's disease patient in Japan. (SPREAD-J study)
Date of disclosure of the study information 2019/06/23
Last modified on 2019/06/23

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Basic information
Public title Multicenter prospective registration study of efficacy and safety of capsule endoscopy in Crohn's disease patient in Japan. (SPREAD-J study)
Acronym SPREAD-J study
Scientific Title Multicenter prospective registration study of efficacy and safety of capsule endoscopy in Crohn's disease patient in Japan. (SPREAD-J study)
Scientific Title:Acronym SPREAD-J study
Region
Japan

Condition
Condition Crohn's disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of study is to evaluate the efficacy, acceptability and safety of capsule endoscopy in Crohn's disease medical care.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection rate and frequency of Crohn's disease lesions by capsule endoscopy (CE)
Key secondary outcomes Correlativity of existing Crohn's disease lesion activity evaluation methods (CDAI, CECDAI, Lewis Score), frequency of adverse events, capsule endoscopy acceptance evaluation, usage of patency capsules, and patency capsule related Adverse events

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
16 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients diagnosed or suspected with CD who scheduled to have CE for all small bowel observation, and if necessary, were known gastrointestinal tract patency within 2 weeks prior to CE by some method including patency capsule.
2) Patients who understand the contents after receiving a written explanation, and receive written consent for free participation.
3) In the case of a minor, a patient who has obtained consent from a representative (guardian).
Key exclusion criteria 1) Patients with unknown digestive tract patency and patients with gastrointestinal obstruction or fistula.
2) Patients who can not receive CE (Patients with cardiac pacemaker insertion, or other electronic medical devices, or dysphagia or dysphagia symptoms).
3) Patients who are pregnant and may be pregnant.
4) In addition, patients who were judged to be unable to participate in research by responsible researcher or shared doctor.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Saruta
Organization The Jikei University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code 105-8461
Address 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, 105-8461, JAPAN
TEL 03-3433-1111
Email m.saruta@jikei.ac.jp

Public contact
Name of contact person
1st name Toshiyuki
Middle name
Last name Sakurai
Organization The Jikei University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code 105-8461
Address 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, 105-8461, JAPAN
TEL 03-3433-1111
Homepage URL
Email to-sakurai@jikei.ac.jp

Sponsor
Institute Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine
Institute
Department

Funding Source
Organization Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine
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 Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine
Address 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, 105-8461, JAPAN
Tel 03-3433-1111
Email to-sakurai@jikei.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
2019 Year 06 Month 23 Day

Related information
URL releasing protocol https://hama-med-cr.net/CRNet_24/rinsho_shiken.aspx?stid=S024
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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 28 Day
Date of IRB
2018 Year 09 Month 28 Day
Anticipated trial start date
2018 Year 09 Month 28 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate the usefulness, receptivity and safety of capsule endoscopy in Crohn's disease medical care

Management information
Registered date
2019 Year 06 Month 23 Day
Last modified on
2019 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041222

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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