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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003037
Receipt No. 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

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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
Email

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
Email toyonaga@med.kobe-u.ac.jp

Sponsor
Institute Kishiwada Tokushukai Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003681

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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