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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018685
Receipt No. 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

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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
Email 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
Email pyloki@yahoo.co.jp

Sponsor
Institute Niigata University Medical and Dental Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021629

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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