UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011140 |
|---|---|
| Receipt number | R000013045 |
| Scientific Title | Evaluation of safety and efficacy for endoscopic biopsy using thin forceps |
| Date of disclosure of the study information | 2013/07/08 |
| Last modified on | 2018/01/09 10:53:25 |
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Basic information
Public title
Evaluation of safety and efficacy for endoscopic biopsy using thin forceps
Acronym
Safety and efficacy of thin forceps
Scientific Title
Evaluation of safety and efficacy for endoscopic biopsy using thin forceps
Scientific Title:Acronym
Safety and efficacy of thin forceps
Region
| Japan |
Condition
Condition
Neoplasms in upper GI tract
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy of thin biopsy forceps compared to normal biopsy forceps
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of specimens which can be evaluated appropriately.
Key secondary outcomes
Endoscopic bleeding time.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Endoscopic biopsy using thin forceps normal forceps
Interventions/Control_2
Endoscopic biopsy using normal forceps
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(A)Scheduled endoscopic treatment of neoplasms in stomach or esophagus.
(B)Neoplasm gross type is 0-IIa/IIb/IIc.
(C)Demarcation line is detectable.
(D)Informed consent.
(E)Performance status(ECOG):0-2.
Key exclusion criteria
(A)Severe hematological, hepatological, or renal disorder accompanied with hemorrhagic tendency.
(B)Other severe comorbidities.
(C)During anticancer chemotherapy.
(D)Poor compliance.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Ono |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo.
TEL
03-3815-5411
satoshi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Ono |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, BUnkyo-ku, Tokyo.
TEL
03-3815-5411
Homepage URL
satoshi-tky@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, the University of Tokyo Hospital.
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
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 | 07 | Month | 08 | 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
| 2013 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 07 | Day |
Last modified on
| 2018 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013045
| 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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