UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029793 |
|---|---|
| Receipt number | R000033952 |
| Scientific Title | Utility of lens coating with liquid ceramic for gastrointestinal endoscopic submucosal dissection |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2018/03/12 10:51:42 |
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Basic information
Public title
Utility of lens coating with liquid ceramic for gastrointestinal endoscopic submucosal dissection
Acronym
Utility of lens coating with liquid ceramic for gastrointestinal endoscopic submucosal dissection
Scientific Title
Utility of lens coating with liquid ceramic for gastrointestinal endoscopic submucosal dissection
Scientific Title:Acronym
Utility of lens coating with liquid ceramic for gastrointestinal endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
gastric tumor(early gastric cancer, gastric adenoma), colorectal tumor(early colorectal cancer, colorectal adenoma)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the utility of lens coating with liquid ceramic for gastrointestinal endoscopic submucosal dissection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visibility(every 15 minutes and the end of procedure)
Key secondary outcomes
procedure time, number of withdrawal of endoscopy during procedure and adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
ESD using endoscope coated with liquid ceramic
Interventions/Control_2
ESD using conventional endoscope
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients who undergo endoscopic submucosal dissecion.
2.Patients who were eligible to this study criteria with written informed consent signed and dated.
Key exclusion criteria
Cases with severe complications are excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hattori Masashi |
Organization
Medical corporation Yamashita Hospital
Division name
Gastroenterology
Zip code
Address
1-3-5, Nakamachi, Ichinomiya
TEL
0586-45-4511
m.hattori@yamashita.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikawa Masakatsu |
Organization
Medical corporation Yamashita Hospital
Division name
Gastroenterology
Zip code
Address
1-3-5, Nakamachi, Ichinomiya
TEL
0586-45-4511
Homepage URL
m.yoshikawa@yamashita.or.jp
Sponsor or person
Institute
Medical corporation Yamashita Hospital
Institute
Department
Personal name
Funding Source
Organization
Medical corporation Yamashita 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
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
| 2017 | Year | 11 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | 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
| 2017 | Year | 11 | Month | 01 | Day |
Last modified on
| 2018 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033952
