UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of Anti-reflux mucosal ablation for refractory GERD: Multi-center prospective study.
Acronym	Efficacy and safety of ARMA for GERD: Multi-center prospective study
Scientific Title	Efficacy and safety of Anti-reflux mucosal ablation for refractory GERD: Multi-center prospective study.
Scientific Title:Acronym	Efficacy and safety of ARMA for GERD: Multi-center prospective study
Region	Japan

Condition
Condition	PPI/PCAB refractory/dependent GERD
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness and safety of ARMA for refractory GERD patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Symptom scores(F scale,GERD-Q,GERD-HRQL,SF-36, Pittsburgh sleep quality index)
Key secondary outcomes	24h pH monitoring(Acid Exposure Time, DeMeester Composite Score, Number of acid exposure, All reflux episode, Symptom Index, Symptom Associated Possibility) Endoscopic image (after 1-3 years) 24h pH monitoring (after 1-3 years) Necessity of PPI/PCAB EPSIS before and after ARMA Adverse event: incidence of bleeding, perforation, stenosis

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Place sub-circumferential endoscopic ablation at the gastric cardia utilizing Argon plasma coagulation(APC).
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	Patient with PPI/PCAB refractory/dependent GERD.
Key exclusion criteria	Inability or unwillingness of patients to give written informed consent. Patient with prominent sliding hernia. Patient with impaired esophageal motility. Pregnancy. Patient with psychiatric/Neurological disorders. Patient with severe comorbidities. Judged unsuitable for this study by the physicians
Target sample size	100

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	+81362046000
Homepage URL
Email	mayo.tanabe@gmail.com

Sponsor
Institute	Showa University Koto Toyosu Hospital, Digestive Diseases Center
Institute
Department

Funding Source
Organization	Showa University Koto Toyosu Hospital, Digestive Diseases Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Fukuoka University Hospital Tottori University Hospital Osaka City University Hospital Aichi Medical University Hospital Shinshu University Hospital
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	+81362046000
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	2021 Year 08 Month 18 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	2021 Year 08 Month 17 Day
Date of IRB	2021 Year 08 Month 17 Day
Anticipated trial start date	2021 Year 08 Month 17 Day
Last follow-up date	2027 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	2021 Year 08 Month 18 Day
Last modified on	2021 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051622