UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009679 |
|---|---|
| Receipt number | R000011351 |
| Scientific Title | Endoscopic Submucosal Dissection Using the Clutch Cutter for Early Stage GI Tract Tumors |
| Date of disclosure of the study information | 2013/01/02 |
| Last modified on | 2018/12/18 19:36:15 |
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Basic information
Public title
Endoscopic Submucosal Dissection Using the Clutch Cutter for Early Stage GI Tract Tumors
Acronym
ESD using the Clutch Cutter for early stage GI tract tumors
Scientific Title
Endoscopic Submucosal Dissection Using the Clutch Cutter for Early Stage GI Tract Tumors
Scientific Title:Acronym
ESD using the Clutch Cutter for early stage GI tract tumors
Region
| Japan |
Condition
Condition
Esophageal cancer
Gastric cancer
Gastric adenoma
Duodenal cancer
Duodenal adenoma
Colo-rectal cancer
Colo-rectal adenoma
Pharyngeal cancer
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Early stage GI tract tumor
Key exclusion criteria
Advanced stage GI tract tumor
Metastasis
Target sample size
2200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuya Akahoshi |
Organization
Aso Iizuka Hospital
Division name
Gastroenterology
Zip code
Address
Yoshio3-83, Iizuka city
TEL
0948-22-3800
kakahoshi2@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Akahoshi |
Organization
Aso iizuka Hospital
Division name
Gastroenterology
Zip code
Address
Yoshio3-83, Iizuka city
TEL
0948-22-3800
Homepage URL
kakahoshi2@aol.com
Sponsor or person
Institute
Dept. of Gastroenterology, Aso Iizuka Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2013 | Year | 01 | Month | 02 | 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
| 2007 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | 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
| 2013 | Year | 01 | Month | 02 | Day |
Last modified on
| 2018 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011351
