UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endoscopic slip knot clip suturing method: A clinical feasibility study
Title of the study (Brief title)	Slip knot clip suturing method
Region	Japan

Condition
Condition	Colonic and duosenal ESD-induced ulcer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to analyze efficacy of slip knot clip suturing method.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Success rate
Key secondary outcomes	Procedure time, bleeding rate, perforation rate

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	Maneuver
Interventions/Control_1	ESD-induced ulcer is completely closed by slip knot clip suturing method.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who undergo colonic or duodenal ESD are included.
Key exclusion criteria	(1) allergy to polyester (2) presence of clinically significant underlying disease (hepatic or renal disease) (3) pregnancy or nursing (4) ineligibility for treatment as determined by a physician
Target sample size	10

Research contact person
Name of lead principal investigator	Toshihiro Nishizawa
Organization	Keio University School of Medicine
Division name	Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	nisizawa@kf7.so-net.ne.jp

Public contact
Name of contact person	Toshihiro Nishizawa
Organization	Keio University School of Medicine
Division name	Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	nisizawa@kf7.so-net.ne.jp

Sponsor
Institute	Keio University
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	Keio University
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	2015 Year 05 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 01 Day
Anticipated trial start date	2015 Year 05 Month 22 Day
Last follow-up date	2016 Year 05 Month 16 Day
Date of closure to data entry	2016 Year 05 Month 16 Day
Date trial data considered complete	2016 Year 05 Month 16 Day
Date analysis concluded	2016 Year 05 Month 16 Day

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

Management information
Registered date	2015 Year 05 Month 15 Day
Last modified on	2016 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020377