UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of effectiveness of wound closure after gastric/ rectal endoscopic submucosal dissection by using endoscopic suturing device.
Title of the study (Brief title)	Evaluation of effectiveness of wound closure after gastric/ rectal endoscopic submucosal dissection by using endoscopic suturing device.
Region	Japan

Condition
Condition	post-ESD ulcer
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of effectiveness and safety of wound closure after gastric/ rectal endoscopic submucosal dissection by using endoscopic suturing device.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Success rate of wound closure after gastric/ rectal ESD by using endoscopic suturing device
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Closure of post-ESD ulcer by using endoscopic submucosal dissection.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who have gastric and rectal lesions with an indication for ESD.
Key exclusion criteria	1.ESD cases for multiple lesions. 2.ESD for cardiac lesion which is difficult for endoscopic suturing. 3.Lesions circumferentially spreading over 1/2. 4.Patients with hematological abnormality.
Target sample size	10

Research contact person
Name of lead principal investigator	Shunsuke Kamba
Organization	The Jikei university school of medicine
Division name	Department of endoscopy
Address	3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo
TEL	03-3433-1111
Email	kanba@jikei.ac.jp

Public contact
Name of contact person	Shunsuke Kamba
Organization	The Jikei university school of medicine
Division name	Department of endoscopy
Address	3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo
TEL	03-3433-1111
Homepage URL
Email	kanba@jikei.ac.jp

Sponsor
Institute	The Jikei university school of medicine Department of endoscopy
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 05 Month 19 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 10 Month 10 Day
Anticipated trial start date	2016 Year 06 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 19 Day
Last modified on	2016 Year 05 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025783