UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017125 |
|---|---|
| Receipt number | 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 15:35:33 |
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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
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
ogotou-gi@keio.jp
Sponsor or person
Institute
Keio University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019864
