UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014136 |
|---|---|
| Receipt number | R000016457 |
| Scientific Title | Assessment of colon motility in patients with megacolon and slow transit constipation using cine-MRI |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2017/06/03 11:23:32 |
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Basic information
Public title
Assessment of colon motility in patients with megacolon and slow transit constipation using cine-MRI
Acronym
Assessment of colon motility using cine-MRI
Scientific Title
Assessment of colon motility in patients with megacolon and slow transit constipation using cine-MRI
Scientific Title:Acronym
Assessment of colon motility using cine-MRI
Region
| Japan |
Condition
Condition
megacolon and slow tlansit constipation (STC)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the pathophysiology of megacolon and STC, we will assess the usefulness of cine-MRI as a diagnostic method, comparing colon motility in healthy people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mean luminal diameter, contraction ratio, and contraction cycle, calculated from each image of cine-MRI.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who are diagnosed megacolon or STC from their symptom, X-rays, and CT scan.
2. Written informed consent was obtained.
Key exclusion criteria
1. Patients with organic digestive tract disease.
2. Patients with current or past history of malignant disease.
3. Patients with current other digestive diseases.
4. Subjects with contraindications to MRI.
5. Patients judged inappropriate for the trial by investigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nakajima |
Organization
Yokohama City University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-9 Fuku-ura Kanazawa-ku Yokohama, Japan
TEL
045-787-2640
nakajima-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumi Inoh |
Organization
Yokohama City University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-9 Fuku-ura Kanazawa-ku Yokohama, Japan
TEL
045-787-2864
Homepage URL
iyumi@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
小田原市立病院(神奈川)Odawara Municipal Hospital, Kanagawa
板橋区医師会病院(東京都)Itabashi Medical Association Hospital, Tokyo
岩手医科大学(岩手県) Iwate Medical University, Iwate
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To understand the pathophisiology of megacolon and STC, we will assess the usefulness of cine-MRI as a diagnostic method, comparing colon motility in healthy people.
Management information
Registered date
| 2014 | Year | 06 | Month | 01 | Day |
Last modified on
| 2017 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016457
