UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018620
Receipt number R000021540
Scientific Title Utility of ultraslim endoscope for colonic stent placement
Date of disclosure of the study information 2015/08/10
Last modified on 2018/09/09 15:49:15

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Basic information

Public title

Utility of ultraslim endoscope for colonic stent placement

Acronym

Utility of ultraslim endoscope for colonic stent placement

Scientific Title

Utility of ultraslim endoscope for colonic stent placement

Scientific Title:Acronym

Utility of ultraslim endoscope for colonic stent placement

Region

Japan


Condition

Condition

Malignant stenosis of distal colon

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

investigate utility of ultraslim endoscope for colonic stent placement

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Technilcal success rate

Key secondary outcomes



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

Use of ultraslim endoscope

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

Center of stenosisi is located anal side of splenic flexure, and oral side of rectum (Ra)
Patient enable to get written informed consent

Key exclusion criteria

Benign colonic stenosis

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Soichi Itaba

Organization

Kyushu Rosai Hospital

Division name

Dept of gastroenterology

Zip code


Address

Sone-kitamachi 1-1,Kitakyushu, Fukuoka

TEL

81-93-471-1121

Email

ita322@yahooo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Soichi Itaba

Organization

Kyushu Rosai Hospital

Division name

Dept of gastroenterology

Zip code


Address

Sone-kitamachi 1-1,Kitakyushu, Fukuoka

TEL

81-93-471-1121

Homepage URL


Email

ita322@yahoo.co.jp


Sponsor or person

Institute

Kyushu Rosai Hospital

Institute

Department

Personal name



Funding Source

Organization

Kyushu Rosai Hospital

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 08 Month 10 Day


Related information

URL releasing protocol


Publication of results

Partially 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

2012 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date

2018 Year 09 Month 09 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 08 Month 10 Day

Last modified on

2018 Year 09 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021540


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name