UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055076 |
|---|---|
| Receipt number | R000062871 |
| Scientific Title | Defect closure after gastric endoscopic submucosal dissection using the reopenable-clip over the line method (ROLM) and self-assembled peptide solution : a randomised controlled trial. |
| Date of disclosure of the study information | 2024/07/26 |
| Last modified on | 2024/10/05 11:46:47 |
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Basic information
Public title
Defect closure after gastric endoscopic submucosal dissection using the reopenable-clip over the line method (ROLM) and self-assembled peptide solution : a randomised controlled trial.
Acronym
Defect closure after gastric ESD using the ROLM and self-assembled peptide solution : A randomised controlled trial.
Scientific Title
Defect closure after gastric endoscopic submucosal dissection using the reopenable-clip over the line method (ROLM) and self-assembled peptide solution : a randomised controlled trial.
Scientific Title:Acronym
Defect closure after gastric ESD using the ROLM and self-assembled peptide solution : A randomised controlled trial.
Region
| Japan |
Condition
Condition
Gastric tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of defect closure after gastric ESD using only the Reopenable-clip over the line method (ROLM) compared with closure using an self-assembled peptide solution in combination with the ROLM.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defect closure rate after ESD, defect closure rate at 2 weeks
Key secondary outcomes
Post-ESD adverse events (postoperative bleeding rate, postoperative perforation rate), defect closure time, number of clips, device cost, Number of times hemostatic forceps were used during closure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
ROLM and self-assembled peptide solution for closure group
Interventions/Control_2
Reopenable-clip over the line method (ROLM) only closure group
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
Gastric ESD defects with a short diameter of 40 mm or less after gastric ESD
Key exclusion criteria
(1) Defects bordering the cardia or pylorus
(2) Defects that extend more than a half circumference of the stomach.
(3)Patients who have been judged as inappropriate for this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tatsuma |
| Middle name | |
| Last name | Nomura |
Organization
Suzuka General Hospital
Division name
Gastroenterology
Zip code
5138630
Address
Suzuka General Hospital, 1275-53, Yamanohana, Yasuduka, suzuka, Mie,
TEL
0593821311
m06076tn@icloud.com
Public contact
Name of contact person
| 1st name | Tatsuma |
| Middle name | |
| Last name | Nomura |
Organization
Suzuka General Hospital
Division name
Gastroenterology
Zip code
5138630
Address
Suzuka General Hospital, 1275-53, Yamanohana, Yasuduka, suzuka, Mie,
TEL
0593821311
Homepage URL
m06076tn@icloud.com
Sponsor or person
Institute
Suzuka General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Suzuka General Hospital Clinical Research Ethics Committee
Address
Suzuka General Hospital, Suzuka, Mie, Japan1275-53, yamanohana, yasuzuka, suzuka, Mie 513-8630, Japa
Tel
0599430501
somu@sch.miekosei.or.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
| 2024 | Year | 07 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 25 | Day |
Last modified on
| 2024 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062871
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
