UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022370 |
|---|---|
| Receipt number | R000025783 |
| Scientific Title | Evaluation of effectiveness of wound closure after gastric/ rectal endoscopic submucosal dissection by using endoscopic suturing device. |
| Date of disclosure of the study information | 2016/05/19 |
| Last modified on | 2016/05/19 20:53:58 |
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Basic information
Public title
Evaluation of effectiveness of wound closure after gastric/ rectal endoscopic submucosal dissection by using endoscopic suturing device.
Acronym
Evaluation of effectiveness of wound closure after gastric/ rectal endoscopic submucosal dissection by using endoscopic suturing device.
Scientific Title
Evaluation of effectiveness of wound closure after gastric/ rectal endoscopic submucosal dissection by using endoscopic suturing device.
Scientific Title:Acronym
Evaluation of effectiveness of wound closure after gastric/ rectal endoscopic submucosal dissection by using endoscopic suturing device.
Region
| Japan |
Condition
Condition
post-ESD ulcer
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of effectiveness and safety of wound closure after gastric/ rectal endoscopic submucosal dissection by using endoscopic suturing device.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of wound closure after gastric/ rectal ESD by using endoscopic suturing device
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
Closure of post-ESD ulcer by using endoscopic submucosal dissection.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have gastric and rectal lesions with an indication for ESD.
Key exclusion criteria
1.ESD cases for multiple lesions.
2.ESD for cardiac lesion which is difficult for endoscopic suturing.
3.Lesions circumferentially spreading over 1/2.
4.Patients with hematological abnormality.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Kamba |
Organization
The Jikei university school of medicine
Division name
Department of endoscopy
Zip code
Address
3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo
TEL
03-3433-1111
kanba@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Kamba |
Organization
The Jikei university school of medicine
Division name
Department of endoscopy
Zip code
Address
3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo
TEL
03-3433-1111
Homepage URL
kanba@jikei.ac.jp
Sponsor or person
Institute
The Jikei university school of medicine
Department of endoscopy
Institute
Department
Personal name
Funding Source
Organization
self funding
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
| 2016 | Year | 05 | Month | 19 | 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
Date of protocol fixation
| 2015 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 03 | 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
| 2016 | Year | 05 | Month | 19 | Day |
Last modified on
| 2016 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025783
