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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013565
Receipt No. R000015850
Scientific Title Treatment effects of Endoscopic Cardiac Mucosal Resection (CMR) for refractory gastroesophageal reflux disease (GERD): a prospective study
Date of disclosure of the study information 2014/03/30
Last modified on 2017/04/03

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Basic information
Public title Treatment effects of Endoscopic Cardiac Mucosal Resection (CMR) for refractory gastroesophageal reflux disease (GERD): a prospective study
Acronym Endoscopic Cardiac Mucosal Resection (CMR) for refractory gastroesophageal reflux disease (GERD)
Scientific Title Treatment effects of Endoscopic Cardiac Mucosal Resection (CMR) for refractory gastroesophageal reflux disease (GERD): a prospective study
Scientific Title:Acronym Endoscopic Cardiac Mucosal Resection (CMR) for refractory gastroesophageal reflux disease (GERD)
Region
Japan

Condition
Condition Refractory gastroesophageal reflux disease
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to investigate the treatment efficacy of endoscopic cardiac mucosal resection (CMR) for refractory gastroesophageal reflux disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Treatment efficacy (subjective and objective symptom)
Key secondary outcomes Treatment completion rate
Incidence of complication rate
Recurrence rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Medication with endoscopic cardiac mucosal resection for refractory gastroesophageal reflux disease.
Interventions/Control_2 Medication without endoscopic cardiac mucosal resection for refractory gastroesophageal reflux disease.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) histologically proven adenocarcinoma.
(2) age 20-80 years.
(3) sufficient organ function.
(4) Performance status(ECOG) 0 to 1.
(4) Having written informed consent
Key exclusion criteria (1) Any patients judged to be unfit to participate in the study, by the investigator.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhiro Inoue, MD, PhD
Organization Showa University Koto-Toyosu Hospital
Division name Digestive Disease Center
Zip code
Address 5-1-38 Toyosu, Koto-ku, Tokyo 135-8577 Japan
TEL 03-6204-6000
Email haruinoue777@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruhiro Inoue, MD, PhD
Organization Showa University Koto-Toyosu Hospital
Division name Digestive Disease Center
Zip code
Address 5-1-38 Toyosu, Koto-ku, Tokyo 135-8577 Japan
TEL 03-6204-6000
Homepage URL
Email haruinoue777@yahoo.co.jp

Sponsor
Institute Digestive Disease Center, Showa University Koto-Toyosu Hospital
Institute
Department

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
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
2014 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2012 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2012 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

Management information
Registered date
2014 Year 03 Month 30 Day
Last modified on
2017 Year 04 Month 03 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015850

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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