UMIN-CTR Clinical Trial

Basic information
Public title	The applicability and safety of endoscopic ablation as a treatment for refractory GERD.(Anti-reflux mucosal ablation;ARMA)
Acronym	The efficacy and safety of endoscopic ablation in the management of refractory GERD.(Anti-reflux mucosal ablation;ARMA)
Scientific Title	The applicability and safety of endoscopic ablation as a treatment for refractory GERD.(Anti-reflux mucosal ablation;ARMA)
Scientific Title:Acronym	The efficacy and safety of endoscopic ablation in the management of refractory GERD.(Anti-reflux mucosal ablation;ARMA)
Region	Japan

Condition
Condition	PPI refractory GERD
Classification by specialty	Gastroenterology Endocrinology and Metabolism Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate effectiveness and safety of endoscopic ablation as a endoscopic fundoplication for refractory GERD patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The efficacy of Anti-reflux mucosal ablation for refractory GERD. f-scale and GERD-Q score 2 months, and 1 year after treatment.
Key secondary outcomes	Adverse event rate.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Create post ablation scar endoscopically for fundoplication.
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	The patient with PPI refractory GERD.
Key exclusion criteria	Inability or unwillingness of patients to give written informed consent. Pregnancy. Judged unsuitable for this study by the physicians
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Haruhiro Middle name Last name Inoue
Organization	Showa University Koto Toyosu Hospital
Division name	Digestive Diseases Center
Zip code	1358511
Address	5-1-38 Toyosu, Koto-ku, Tokyo, Japan
TEL	08039002330
Email	mayo.tanabe@gmail.com

Public contact
Name of contact person	1st name Mayo Middle name Last name Tanabe
Organization	Showa University Koto Toyosu Hospital
Division name	Digestive Diseases Center
Zip code	1358511
Address	5-1-38 Toyosu Koto-ku, Tokyo, Japan
TEL	08039002330
Homepage URL
Email	mayo.tanabe@gmail.com

Sponsor
Institute	Showa University
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	Showa University Koto Toyosu Hospital
Address	5-1-38 Toyosu Koto-ku Tokyo, Japan
Tel	03-6204-6361
Email	th_irb@ofc.showa-u.ac.jp

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	2018 Year 04 Month 11 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	2018 Year 04 Month 10 Day
Date of IRB	2017 Year 09 Month 29 Day
Anticipated trial start date	2018 Year 04 Month 18 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 10 Day
Last modified on	2019 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036718