UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the efficacy of endoscopic hemostasis using an detachable snare against diverticular bleeding of colon
Title of the study (Brief title)	The efficacy of endoscopic hemostasis using an detachable snare for diverticular bleeding of colon
Region	Japan

Condition
Condition	diverticular bleeding of colon
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the efficacy and safety of endoscopic hemostasis using an detachable snare against diverticular bleeding of colon
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rebleeding rate
Key secondary outcomes	Bleeding source identification rate Effective rate Complications Hemostatic procedure time Factor of unsuccessful

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	Ligation hemostasis by detachable snare
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	Patients with bloody stool who colon diverticulum bleeding was suspected
Key exclusion criteria	Patients with severe underlying disease Patients with a high degree of bleeding tendency
Target sample size	120

Research contact person
Name of lead principal investigator	Ichinosuke Hyodo
Organization	Faculty of Medicine, University of Tsukuba
Division name	Gastroenterology
Address	1-1-1Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-3218
Email	ihyodo@md.tsukuba.ac.jp

Public contact
Name of contact person	Toshiaki Narasaka
Organization	University of Tsukuba Hospital
Division name	Division of endoscopy
Address	2-1-1Amakubo, Tsukuba, Ibaraki, Japan
TEL	029-853-3218
Homepage URL
Email	narasaka-gi@umin.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

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)

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 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 01 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 24 Day
Last modified on	2018 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018986