UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018685 |
|---|---|
| Receipt number | R000021629 |
| Scientific Title | Peroral endoscopic muscle biopsy (POEM-b) for intestinal motility disorders |
| Date of disclosure of the study information | 2015/08/16 |
| Last modified on | 2018/07/09 18:36:58 |
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Basic information
Public title
Peroral endoscopic muscle biopsy (POEM-b) for intestinal motility disorders
Acronym
Peroral endoscopic muscle biopsy (POEM-b)
Scientific Title
Peroral endoscopic muscle biopsy (POEM-b) for intestinal motility disorders
Scientific Title:Acronym
Peroral endoscopic muscle biopsy (POEM-b)
Region
| Japan |
Condition
Condition
intestinal motility disorders
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Histopathological assessment of muscularis propria in intestinal motility disorders
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The efficacy and safety of POEM-b
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Peroral endoscopic muscle biopsy (POEM-b)
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
Intestinal motility disorders
Informed consent
Key exclusion criteria
Severe complication
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Terai |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
757-1, Asahimachidori, Chuo-ku, Niigata city
TEL
025-223-6161
terais@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Sato |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
757-1, Asahimachidori, Chuo-ku, Niigata city
TEL
025-223-6161
Homepage URL
pyloki@yahoo.co.jp
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
Niigata University Medical and Dental Hospital
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
| 2015 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/27699951
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
Main results already published
Date of protocol fixation
| 2014 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | 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
Management information
Registered date
| 2015 | Year | 08 | Month | 15 | Day |
Last modified on
| 2018 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021629
