UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046253 |
|---|---|
| Receipt number | R000052782 |
| Scientific Title | Efficacy and safety of a novel closure method Loop9 for mucosal defect after Colorectal Endoscopic submucosal dissection |
| Date of disclosure of the study information | 2021/12/02 |
| Last modified on | 2023/01/18 09:19:51 |
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Basic information
Public title
Efficacy and safety of a novel closure method Loop9 for mucosal defect after Colorectal Endoscopic submucosal dissection
Acronym
Efficacy and safety of a novel closure method Loop9 for mucosal defect after Colorectal Endoscopic submucosal dissection
Scientific Title
Efficacy and safety of a novel closure method Loop9 for mucosal defect after Colorectal Endoscopic submucosal dissection
Scientific Title:Acronym
Efficacy and safety of a novel closure method Loop9 for mucosal defect after Colorectal Endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
Colorectal tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to assess the efficacy and safety of the loop 9 method for closure of the mucosal defects after colorectal ESD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete closure rate
Key secondary outcomes
Sustained closure rate, whole closure time (per defect), closure time (per one loop9 closure), defect size, location, number of additional clips used, length of hospital stays after ESD, and delayed AEs such as bleeding, delayed perforation, and PECS.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
The inclusion criterion for participation was the patients underwent loop9 closure after colorectal endoscopic submucosal dissection for early colorectal tumor.
Key exclusion criteria
The exclusion criteria were age < 20 years and serious combined diseases.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mayo |
| Middle name | Tanabe |
| Last name | Tanabe |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive Diseases Center
Zip code
1358577
Address
5-1-38 Toyosu Kotoku Tokyo
TEL
0362046000
mayo.tanabe@gmail.com
Public contact
Name of contact person
| 1st name | Mayo |
| Middle name | Tanabe |
| Last name | Tanabe |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive Diseases Center
Zip code
1358577
Address
5-1-38 Toyosu Koto-ku Tokyo, Japan
TEL
0362046000
Homepage URL
mayo.tanabe@gmail.com
Sponsor or person
Institute
Showa University Koto Toyosu Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Select a State/Province
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Koto Toyosu Hospital
Address
5-1-38 Toyosu Koto-ku, Tokyo, Japan
Tel
0362046000
th_irb@ofc.showa-u.ac.jp
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
| 2021 | Year | 12 | Month | 02 | 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
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 01 | Day |
Last modified on
| 2023 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052782
