UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037143 |
|---|---|
| Receipt number | 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 | 2023/02/04 12:19:52 |
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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
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
to-sakurai@jikei.ac.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine
Institute
Department
Personal name
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
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
Completed
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
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 01 | Day |
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
| 2023 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041222
| 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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| Registered date | File name |
