UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024375 |
|---|---|
| Receipt number | R000028063 |
| Scientific Title | The efficacy of new bipolar hemostatic forceps for endoscopic resection |
| Date of disclosure of the study information | 2016/10/13 |
| Last modified on | 2017/10/18 16:03:27 |
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Basic information
Public title
The efficacy of new bipolar hemostatic forceps for endoscopic resection
Acronym
The efficacy of new hemostatic forceps for ER
Scientific Title
The efficacy of new bipolar hemostatic forceps for endoscopic resection
Scientific Title:Acronym
The efficacy of new hemostatic forceps for ER
Region
| Japan |
Condition
Condition
the gastrointestinal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficasy of new bipolar hemostatic forceps for bleeding during endoscopic resection of the GI tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the successful rate of hemostasis
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
new bipolar hamostatic forceps
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
Patient for gastrointestinal tumor and subjected to endoscopic resection.
Key exclusion criteria
Patient who judged that we were inappropriate to perform examination safely.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohisa Yahagi |
Organization
Keio University
Division name
Center for Research and Development of Minimally Invasive Treatment, Cancer Center
Zip code
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL
03-5363-3437
yahagi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasutoshi Ochiai |
Organization
Keio University
Division name
Center for Research and Development of Minimally Invasive Treatment, Cancer Center
Zip code
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL
03-5363-3437
Homepage URL
yochiai.a7@keio.jp
Sponsor or person
Institute
Center for Research and Development of Minimally Invasive Treatment, Cancer Center, Keio University
Institute
Department
Personal name
Funding Source
Organization
Center for Research and Development of Minimally Invasive Treatment, Cancer Center, Keio University
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
| 2016 | Year | 10 | Month | 13 | 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
| 2016 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 13 | 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
| 2016 | Year | 10 | Month | 12 | Day |
Last modified on
| 2017 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028063
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
