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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036718


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name