UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053374 |
|---|---|
| Receipt number | R000060917 |
| Scientific Title | Efficacy of the Clip with Line Pulley Securing (CLiPS) method after gastric endoscopic submucosal dissection: A prospective study |
| Date of disclosure of the study information | 2024/01/17 |
| Last modified on | 2025/12/31 00:06:34 |
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Basic information
Public title
Efficacy of the Clip with Line Pulley Securing (CLiPS) method after gastric endoscopic submucosal dissection: A prospective study
Acronym
Efficacy of the Clip with Line Pulley Securing (CLiPS) method after gastric endoscopic submucosal dissection: A prospective study
Scientific Title
Efficacy of the Clip with Line Pulley Securing (CLiPS) method after gastric endoscopic submucosal dissection: A prospective study
Scientific Title:Acronym
Efficacy of the Clip with Line Pulley Securing (CLiPS) method after gastric endoscopic submucosal dissection: A prospective study
Region
| Japan |
Condition
Condition
Gastric lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and safety of Clip with Line Pulley Securing(CLiPS) in mucosal defect closure after ESD of gastric lesions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of closure with CLiPS method
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
Closure with CLiPS 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
Cases in which ESD is performed for early gastric cancer or gastric adenoma based on the Japanese Endoscopy Society (JGES) standards. The applicant's consent to participate in clinical research is obtained in writing.
Key exclusion criteria
Cases with severe complications are excluded.Cases of mucosal defects extending into the esophagus and duodenum after resection.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | TOMOYA |
| Middle name | |
| Last name | KIMURA |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastrointestinal Endoscopy
Zip code
141-8625
Address
5-9-22 higashigotanda, Shinagawa-ku, Tokyo, JAPAN
TEL
03-3448-6111
tomoya.kimura.084@gmail.com
Public contact
Name of contact person
| 1st name | TOMOYA |
| Middle name | |
| Last name | KIMURA |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastrointestinal Endoscopy
Zip code
141-8625
Address
5-9-22 higashigotanda, Shinagawa-ku, Tokyo, JAPAN
TEL
03-3448-6111
Homepage URL
tomoya.kimura.084@gmail.com
Sponsor or person
Institute
NTT Medial Center Tokyo
Institute
Department
Personal name
Funding Source
Organization
NTT Medical Center Tokyo
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
NTT Medical Center Tokyo
Address
5-9-22 higashigotanda, Shinagawa-ku, Tokyo, JAPAN
Tel
03-3448-6111
tomoya.kimura.084@gmail.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
| 2024 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000060917
Publication of results
Unpublished
Result
URL related to results and publications
Under preparation for publication
Number of participants that the trial has enrolled
50
Results
Complete defect closure was achieved in all cases. (50/50)
Results date posted
| 2025 | Year | 12 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study was conducted in patients with lesions suspected of early gastric cancer or gastric adenoma based on endoscopic diagnosis.
Participant flow
The approved written information and informed consent documents were provided to the patients, and sufficient explanations were given both in writing and verbally. Written informed consent was obtained from all patients based on their free will.
Adverse events
No adverse events occurred during or after CLiPS technique.
Outcome measures
A second-look endoscopy was performed on postoperative day 2 to assess whether the mucosal closure was maintained.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 28 | 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 | 01 | Month | 17 | Day |
Last modified on
| 2025 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060917
