UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016889
Receipt number R000018986
Scientific Title A study of the efficacy of endoscopic hemostasis using an detachable snare against diverticular bleeding of colon
Date of disclosure of the study information 2015/04/01
Last modified on 2018/05/27 10:41:16

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Basic information

Public title

A study of the efficacy of endoscopic hemostasis using an detachable snare against diverticular bleeding of colon

Acronym

The efficacy of endoscopic hemostasis using an detachable snare for diverticular bleeding of colon

Scientific Title

A study of the efficacy of endoscopic hemostasis using an detachable snare against diverticular bleeding of colon

Scientific Title:Acronym

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

1st name
Middle name
Last name Ichinosuke Hyodo

Organization

Faculty of Medicine, University of Tsukuba

Division name

Gastroenterology

Zip code


Address

1-1-1Tennodai, Tsukuba, Ibaraki, Japan

TEL

029-853-3218

Email

ihyodo@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiaki Narasaka

Organization

University of Tsukuba Hospital

Division name

Division of endoscopy

Zip code


Address

2-1-1Amakubo, Tsukuba, Ibaraki, Japan

TEL

029-853-3218

Homepage URL


Email

narasaka-gi@umin.ac.jp


Sponsor or person

Institute

University of Tsukuba

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


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 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2015 Year 04 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018986


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name