UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Direct injection of 1L hypertonic polyethylene glycol to gastrointestinal tract using transnasal endoscopy as bowel preparation for colonoscopy; single arm prospective study.
Title of the study (Brief title)	Direct injection of 1L hypertonic polyethylene glycol to gastrointestinal tract using transnasal endoscopy as bowel preparation for colonoscopy; single arm prospective study.
Region	Japan

Condition
Condition	colonic disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Safety of direct injection of 1L hypertonic polyethylene glycol to gastrointestinal tract using transnasal endoscopy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complication 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	Prevention
Type of intervention	Medicine
Interventions/Control_1	A group of direct injection of 1L hypertonic polyethylene glycol to gastrointestinal tract using transnasal endoscopy
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	18 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	patiens who need to undergo both colonoscopy and esophagogastroduodenoscopy
Key exclusion criteria	1)past medical hitory of gastrectomy 2)active colitis, inflammatory bowel disease 3)suspected stenosis of gastrointestinal tract 4)contraindication of transnasal endoscopy 5)detected active bleeding, stenosis or perforation during esophagogastroduodenoscopy 6)disagree to participate in this research with written informed consent 7)younger than 18yr 8)older than 74yr 9)severe comorbidity such as heart failure, liver cirrhosis or renal failure
Target sample size	30

Research contact person
Name of lead principal investigator	Asai Satoshi
Organization	Tane General Hospital
Division name	Gastroenterology
Address	1-21-21 Kujouminami Nishiku Osaka Japan
TEL	06-6581-1071
Email	bonyaritetsu1226@hotmail.co.jp

Public contact
Name of contact person	Asai Satoshi
Organization	Tane General Hospital
Division name	Gastroenterology
Address	1-21-21 Kujouminami Nishiku Osaka Japan
TEL	06-6581-1071
Homepage URL
Email	bonyaritetsu1226@hotmail.co.jp

Sponsor
Institute	Tane General Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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 07 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 30 Day
Anticipated trial start date	2015 Year 07 Month 15 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 09 Day
Last modified on	2016 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021133