UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003037 |
|---|---|
| Receipt number | R000003681 |
| Scientific Title | Performance of a novel ball-tipped Flush knife for endoscopic submucosal dissection |
| Date of disclosure of the study information | 2010/01/14 |
| Last modified on | 2010/01/14 18:03:48 |
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Basic information
Public title
Performance of a novel ball-tipped Flush knife for endoscopic submucosal dissection
Acronym
Performance of Flush knife BT for ESD
Scientific Title
Performance of a novel ball-tipped Flush knife for endoscopic submucosal dissection
Scientific Title:Acronym
Performance of Flush knife BT for ESD
Region
| Japan |
Condition
Condition
Early gastrointestinal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the results of a novel needle knife with a ball tip (Flush knife-BT) for ESD of early gastrointestinal neoplasms, with particular emphasis on hemostasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Efficacy of procedural hemostasis, defined as the number of intraoperative bleeding points and the number of points necessitating the use of hemostatic forceps.
Key secondary outcomes
Procedure time, procedure speed, en bloc resection rate, en bloc R0 resection rate, perforation rate and postoperative bleeding rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Standard Flush knife group
Interventions/Control_2
New ball-tipped Flush knife (Flush knife-BT) group
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
Intramucosal or slightly-invaded submucosal gastrointestinal neoplasms were considered eligible
Key exclusion criteria
Patients with ulcer scars or previously treated lesions were excluded, as were those with severe organ failure, or who had undergone anticoagulant/antiplatelet therapy.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Toyonaga |
Organization
Kobe University Hospital
Division name
Department of Endoscopy
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe,Japan
TEL
078-382-6305
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Toyonaga |
Organization
Kobe University Hospital
Division name
Department of Endoscopy
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6305
Homepage URL
toyonaga@med.kobe-u.ac.jp
Sponsor or person
Institute
Kishiwada Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
Fujinon Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
岸和田徳洲会病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 14 | 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
Results
Oral presentation, part of session ASGE New Technology (Therapy) - 1, DDW 2009, Chicago
Title:Effectiveness of the Ball Tipped Flush Knife in Endoscopic Submucosal Dissection for the Treatment of GI Neoplasia
Track: Endoscopy: New therapeutic technology, Endoscopic Technology
Location: McCormick Place
Date: Monday Jun 1, 2009
Time: 8:00 AM - 5:00 PM
Speaker: Presenter: Takashi Toyonaga 1 , Mariko Man-I 1 , Yoshinori Morita 2 , Hiromu Kutsumi 2 , Hideto Inokuchi 2 , Takeshi Azuma 2 (M1519 | Company:1. Endoscopy, Kobe University Hospital, Kobe, Japan. 2. Gastroenterology, Kobe University, Kobe, Japan.
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
| 2008 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 14 | Day |
Last modified on
| 2010 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003681
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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