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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016126
Receipt No. R000018728
Scientific Title Questionnaire study of a single institution on the effectiveness of Peroral Endoscopic Myotomy (POEM) for esophageal achalasia
Date of disclosure of the study information 2017/01/06
Last modified on 2015/01/05

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Basic information
Public title Questionnaire study of a single institution on the effectiveness of Peroral Endoscopic Myotomy (POEM) for esophageal achalasia
Acronym Study of the effectiveness of Peroral Endoscopic Myotomy (POEM) for esophageal achalasia
Scientific Title Questionnaire study of a single institution on the effectiveness of Peroral Endoscopic Myotomy (POEM) for esophageal achalasia
Scientific Title:Acronym Study of the effectiveness of Peroral Endoscopic Myotomy (POEM) for esophageal achalasia
Region
Japan

Condition
Condition esophageal achalasia
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 study the usefulness of POEM for esophageal achalasia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of Eckardt score before and after treatment.
Key secondary outcomes

Base
Study type

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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 intervention of POEM
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria a. Patients with esophageal achalasia which has a current symptoms.
b. Patients had esophagus fluoroscopy and upper gastrointestinal endoscopy for diagnosis as esophageal acalasia.
c. Esophageal pressure measurement is not necessarily performed.
d. Treatment history (medicine, endoscopic balloon dilation, surgical history) does not matter.
e. Achalasia form classification, the degree of dilation is not limited.
f. Patientsdetermined to be reasonable for POEM in Gastroenterology Surgery Conference.
Key exclusion criteria a. Patients have risk factors for POEM clinically.
b. minors.
c. Patients have no imformed consent of POEM.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Okada
Organization Okayama University Hospital
Division name Department of Endoscopy
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL 086-235-7219
Email hiro@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuusaku Sugihara
Organization Okayama University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL 086-235-7219
Homepage URL
Email y.sugi117@gmail.com

Sponsor
Institute Okayama University Graduate School of Medicine
Institute
Department

Funding Source
Organization Okayama University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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
2017 Year 01 Month 06 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 Open public recruiting
Date of protocol fixation
2016 Year 11 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 01 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

Management information
Registered date
2015 Year 01 Month 05 Day
Last modified on
2015 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018728

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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