UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020245
Receipt number R000023376
Scientific Title Endoscopic esophageal myotomy for achalasia and esophageal motor function disorders
Date of disclosure of the study information 2015/12/17
Last modified on 2016/01/07 18:39:03

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Basic information

Public title

Endoscopic esophageal myotomy for achalasia and esophageal motor function disorders

Acronym

Endoscopic esophageal myotomy for achalasia and esophageal motor function disorders

Scientific Title

Endoscopic esophageal myotomy for achalasia and esophageal motor function disorders

Scientific Title:Acronym

Endoscopic esophageal myotomy for achalasia and esophageal motor function disorders

Region

Japan


Condition

Condition

Esophageal achalasia and esophageal motor function disorders

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will evaluate the efficacy and less invasiveness of submucosal endoscopic esophageal myotomy for esophageal achalasia and esophageal motor function disorders.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III


Assessment

Primary outcomes

Relapse-free survival

Key secondary outcomes

Intra and post-treatment morbidity, success rate


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Submucosal endoscopic esophageal myotomy for esophageal achalasia and other diseases under general anesthesia.

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

3 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Esophageal achalasia and esophageal motor function disorders
Informed consent

Key exclusion criteria

Under 3 years old

Target sample size

320


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruhiro Inoue, MD, PhD

Organization

Showa University Koto Toyosu Hospital

Division name

Digestive Disease Center

Zip code


Address

5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan

TEL

03-6204-6000

Email

haruinoue777@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Haruhiro Inoue, MD, PhD

Organization

Showa University Koto Toyosu Hospital

Division name

Digestive Disease Center

Zip code


Address

5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan

TEL

03-6204-6000

Homepage URL


Email

haruinoue777@yahoo.co.jp


Sponsor or person

Institute

Digestive Disease Center, Showa University Koto Toyosu Hospital

Institute

Department

Personal name



Funding Source

Organization

Digestive Disease Center, Showa University Koto Toyosu Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 12 Month 17 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

2015 Year 12 Month 15 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 17 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 12 Month 17 Day

Last modified on

2016 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023376


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name