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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017125
Receipt No. R000019864
Scientific Title A pilot study of feasibility of endoscopic hand-suturing for mucosal defect after endoscopic resection
Date of disclosure of the study information 2015/04/14
Last modified on 2016/02/10

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Basic information
Public title A pilot study of feasibility of endoscopic hand-suturing for mucosal defect after endoscopic resection
Acronym feasibility of endoscopic hand-suturing
Scientific Title A pilot study of feasibility of endoscopic hand-suturing for mucosal defect after endoscopic resection
Scientific Title:Acronym feasibility of endoscopic hand-suturing
Region
Japan

Condition
Condition Gastric tumor 3 cm or less in size as a candidate for endoscopic resection
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Assessment of feasibility and efficacy of endoscopic hand-suturing (EHS) for a mucosal defect after endosocpic resection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of achievement of EHS
Key secondary outcomes The rate of complications, delayed bleeding, and maintenance after suturing

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
Maneuver
Interventions/Control_1 Endoscopic hand-suturing
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 20 years of age and older having gastric tumor 3 cm or less which was diagnosed as a candidate for endoscopic resection
Key exclusion criteria Cases difficult to resect e.g., located on the fornix, greater curvature of the upper third, and lesser curvature over the angulus
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naohisa Yahagi
Organization Keio University, School of Medicine
Division name Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email yahagi.keio@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Goto
Organization Keio University, School of Medicine
Division name Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-5363-3437
Homepage URL
Email ogotou-gi@keio.jp

Sponsor
Institute Keio University, School of Medicine
Institute
Department

Funding Source
Organization The Foundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization Non profit foundation
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

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 14 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
2015 Year 01 Month 08 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 07 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
2015 Year 04 Month 13 Day
Last modified on
2016 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019864

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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