UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032190 |
|---|---|
| Receipt number | R000036718 |
| Scientific Title | The applicability and safety of endoscopic ablation as a treatment for refractory GERD.(Anti-reflux mucosal ablation;ARMA) |
| Date of disclosure of the study information | 2018/04/11 |
| Last modified on | 2019/12/27 10:32:44 |
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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
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
mayo.tanabe@gmail.com
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036718
