UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018262 |
|---|---|
| Receipt number | R000021133 |
| Scientific Title | Direct injection of 1L hypertonic polyethylene glycol to gastrointestinal tract using transnasal endoscopy as bowel preparation for colonoscopy; single arm prospective study. |
| Date of disclosure of the study information | 2015/07/09 |
| Last modified on | 2016/11/01 13:38:10 |
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Basic information
Public title
Direct injection of 1L hypertonic polyethylene glycol to gastrointestinal tract using transnasal endoscopy as bowel preparation for colonoscopy; single arm prospective study.
Acronym
Direct injection of 1L hypertonic polyethylene glycol to gastrointestinal tract using transnasal endoscopy as bowel preparation for colonoscopy; single arm prospective study.
Scientific Title
Direct injection of 1L hypertonic polyethylene glycol to gastrointestinal tract using transnasal endoscopy as bowel preparation for colonoscopy; single arm prospective study.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Asai Satoshi |
Organization
Tane General Hospital
Division name
Gastroenterology
Zip code
Address
1-21-21 Kujouminami Nishiku Osaka Japan
TEL
06-6581-1071
bonyaritetsu1226@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asai Satoshi |
Organization
Tane General Hospital
Division name
Gastroenterology
Zip code
Address
1-21-21 Kujouminami Nishiku Osaka Japan
TEL
06-6581-1071
Homepage URL
bonyaritetsu1226@hotmail.co.jp
Sponsor or person
Institute
Tane General Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
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 | 30 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021133
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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