UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of ultraslim endoscope for colonic stent placement
Title of the study (Brief title)	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	Soichi Itaba
Organization	Kyushu Rosai Hospital
Division name	Dept of gastroenterology
Address	Sone-kitamachi 1-1,Kitakyushu, Fukuoka
TEL	81-93-471-1121
Email	ita322@yahooo.co.jp

Public contact
Name of contact person	Soichi Itaba
Organization	Kyushu Rosai Hospital
Division name	Dept of gastroenterology
Address	Sone-kitamachi 1-1,Kitakyushu, Fukuoka
TEL	81-93-471-1121
Homepage URL
Email	ita322@yahoo.co.jp

Sponsor
Institute	Kyushu Rosai Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021540