UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045188 |
|---|---|
| Receipt number | R000051622 |
| Scientific Title | Efficacy and safety of Anti-reflux mucosal ablation for refractory GERD: Multi-center prospective study. |
| Date of disclosure of the study information | 2021/08/18 |
| Last modified on | 2021/08/18 16:43:22 |
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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
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
mayo.tanabe@gmail.com
Sponsor or person
Institute
Showa University Koto Toyosu Hospital, Digestive Diseases Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051622
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
