UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010870 |
|---|---|
| Receipt number | R000012483 |
| Scientific Title | Endoscopic gastric tumor resection by hybrid knife with ERBE JET2 |
| Date of disclosure of the study information | 2013/06/04 |
| Last modified on | 2019/12/09 14:34:32 |
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Basic information
Public title
Endoscopic gastric tumor resection by hybrid knife with ERBE JET2
Acronym
Endoscopic gastric tumor resection by hybrid knife
Scientific Title
Endoscopic gastric tumor resection by hybrid knife with ERBE JET2
Scientific Title:Acronym
Endoscopic gastric tumor resection by hybrid knife
Region
| Japan |
Condition
Condition
Early gastric cancer, gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Shortening of the endoscopic treatment time
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endoscopic treatment time
Key secondary outcomes
The rate of curative resection by histopathology and complication such as bleeding or perforation
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
Patients with early gastric cancer or gastric adenoma who will be treated until 3/31/2018
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
Patients with early gastric cancer or gastric adenoma which are eligible for endoscopic resection
Key exclusion criteria
Patients without consent to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Suzuki |
Organization
University of Tsukuba Hospital
Division name
Gastrointestinal Endoscopy Division
Zip code
305-8576
Address
2-1-1 amakubo,tsukuba,ibaraki,Japan
TEL
029-853-3218
hideoszk@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Hideo |
| Middle name | |
| Last name | Suzuki |
Organization
University of Tsukuba Hospital
Division name
Gastrointestinal Endoscopy Division
Zip code
305-8576
Address
2-1-1 Amakubo,Tsukuba,Ibaraki,JAPAN
TEL
029-853-3218
Homepage URL
hideoszk@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
University of Tsukuba hospital
Address
2-1-1 Amakubo,Tsukuba,Ibaraki
Tel
0298533218
hideoszk@md.tsukuba.ac.jp
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
筑波大学附属病院(茨城県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
23
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
| 2013 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 04 | Day |
Last modified on
| 2019 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012483
