UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017583 |
|---|---|
| Receipt number | R000020377 |
| Scientific Title | Endoscopic slip knot clip suturing method: A clinical feasibility study |
| Date of disclosure of the study information | 2015/05/22 |
| Last modified on | 2016/05/16 07:41:13 |
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Basic information
Public title
Endoscopic slip knot clip suturing method:
A clinical feasibility study
Acronym
Slip knot clip suturing method
Scientific Title
Endoscopic slip knot clip suturing method:
A clinical feasibility study
Scientific Title:Acronym
Slip knot clip suturing method
Region
| Japan |
Condition
Condition
Colonic and duosenal ESD-induced ulcer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to analyze efficacy of slip knot clip suturing method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Success rate
Key secondary outcomes
Procedure time, bleeding rate, perforation rate
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
ESD-induced ulcer is completely closed by slip knot clip suturing method.
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 who undergo colonic or duodenal ESD are included.
Key exclusion criteria
(1) allergy to polyester
(2) presence of clinically significant underlying disease (hepatic or renal disease)
(3) pregnancy or nursing
(4) ineligibility for treatment as determined by a physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiro Nishizawa |
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
TEL
03-3353-1211
nisizawa@kf7.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Nishizawa |
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
TEL
03-3353-1211
Homepage URL
nisizawa@kf7.so-net.ne.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Self funding
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 | 05 | Month | 22 | 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 | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 16 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 16 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 16 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 15 | Day |
Last modified on
| 2016 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020377
