UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044991 |
|---|---|
| Receipt number | R000051297 |
| Scientific Title | Reopenable Clip Over the line Method (ROLM) for mucosal defect after gastric endoscopic submucosal dissection: a prospective study |
| Date of disclosure of the study information | 2021/07/29 |
| Last modified on | 2024/01/30 09:03:10 |
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Basic information
Public title
Reopenable Clip Over the line Method (ROLM) for mucosal defect after gastric endoscopic submucosal dissection: a prospective study
Acronym
Reopenable Clip Over the line Method (ROLM) for mucosal defect after gastric endoscopic submucosal dissection: a prospective study
Scientific Title
Reopenable Clip Over the line Method (ROLM) for mucosal defect after gastric endoscopic submucosal dissection: a prospective study
Scientific Title:Acronym
Reopenable Clip Over the line Method (ROLM) for mucosal defect after gastric endoscopic submucosal dissection: a prospective study
Region
| Japan |
Condition
Condition
Early gastric cancer and gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety of reopenable-clip over the line method (ROLM) in mucosal defect closure after ESD of gastric adenoma and early gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate whether mucosal defect after ESD is closed by reopenable-clip over the line method using conventional clip.
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
| Maneuver |
Interventions/Control_1
For mucosal defect after ESD, only reopenable-clip are used and closed using reopenable-clip over the line 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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Early gastric cancer and adenoma suitable for ESD. Cases with written and oral informed consent are included.
Key exclusion criteria
Cases with severe complications are excluded.
Post ESD mucosal defects bordering the pylorus or cardia. Mucosal defect after ESD is larger than half circumference of the gastric lumen.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Oyamada |
Organization
Ise Red Cross Hospital
Division name
Gastroenterology
Zip code
516-8512
Address
1-471-2 Funae, Ise, Mie, Japan 516-8512
TEL
0596-28-2171
oyamada1398@cocoa.plala.or.jp
Public contact
Name of contact person
| 1st name | Tatsuma |
| Middle name | |
| Last name | Nomura |
Organization
Mie Prefectural Shima Hospital
Division name
Gastroenterology
Zip code
517-0595
Address
1257 Ugata, Ago, Shima, Mie 517-0595, Japan
TEL
0599-43-0501
Homepage URL
m06076tn@icloud.com
Sponsor or person
Institute
Ise Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Ise Red Cross Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ise Red Cross Hospital
Address
1-471-2 Funae, Ise, Mie, Japan 516-8512
Tel
0596-28-2171
m06076tn@icloud.com
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 | 07 | Month | 29 | 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
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 01 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2024 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051297
