UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057849 |
|---|---|
| Receipt number | R000066028 |
| Scientific Title | Feasibility of the "Clip with Line Pulley Securing (CLiPS)" Technique for Closure After Colorectal ESD: A Prospective Study |
| Date of disclosure of the study information | 2025/05/13 |
| Last modified on | 2025/05/13 08:26:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Feasibility of the "Clip with Line Pulley Securing (CLiPS)" Technique for Closure After Colorectal ESD: A Prospective Study
Acronym
C-CLiPS Study
Scientific Title
Feasibility of the "Clip with Line Pulley Securing (CLiPS)" Technique for Closure After Colorectal ESD: A Prospective Study
Scientific Title:Acronym
C-CLiPS Study
Region
| Japan |
Condition
Condition
Colorectal Tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and safety of the CLiPS technique for post colorectal ESD defect closure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete Closure rate
Key secondary outcomes
1. Evaluation of the Closure Technique (Time required for defect closure,Types and number of devices used, Procedure-related adverse events)
2. Incidence of Post-closure Adverse Events (Delayed bleeding, Delayed perforation, Other complications)
3. Closure Integrity (Maintenance of defect closure at 2 days post-procedure)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Post-colorectal ESD defects is approximated by the CLiPS technique, which involves pulling the mucosa together with a clip-line and securing with an endoloop.
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
Inclusion Criteria
Age over 20 years at registration.
ECOG Performance Status of 0 or 1.
Lesion size between 20-50 mm.
The most recent blood test within 30 days prior to registration meets all of the following criteria (no blood transfusion within 14 days prior to the test used for registration)
Hemoglobin over 9 g/dL
Platelet count above 100,000
AST/ALT below 100
Serum creatinine below 2.0 mg/dL
Able to be followed for 28 days after treatment.
Written informed consent has been obtained.
Key exclusion criteria
Exclusion Criteria
History of endoscopic treatment for lower gastrointestinal lesions within 28 days prior to enrollment.
Planned endoscopic treatment for the lower gastrointestinal tract within 28 days after the procedure.
Planned treatment of multiple lesions at the same time.
Presence of active inflammatory bowel disease (ulcerative colitis or Crohn's disease).
History of radiation therapy to the planned ESD area.
Women who are possibly pregnant, currently pregnant, or breastfeeding.
Presence of psychiatric conditions that impair understanding of the study.
History of myocardial infarction or unstable angina within the past 3 months.
Presence of a coagulation disorder (regardless of antithrombotic medication use).
Active bacterial or fungal infection (defined as fever over 38.5 degrees with supporting radiologic or microbiological evidence).
Presence of respiratory disease requiring continuous oxygen therapy.
Uncontrolled hypertension.
Any other condition deemed inappropriate for study participation by the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamazaki |
Organization
NTT Medical Center Tokyo
Division name
Gastrointestinal Endoscopy
Zip code
141-0022
Address
5-9-22Higashi Gotanda, Shinagawa, Tokyo
TEL
03-3448-6111
hiroyama90@hotmail.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamazaki |
Organization
NTT Medical Center Tokyo
Division name
Gastrointestinal Endoscopy
Zip code
141-0022
Address
5-9-22Higashi Gotanda, Shinagawa, Tokyo
TEL
03-3448-6111
Homepage URL
hiroyama90@hotmail.com
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Hiroshi Yamazaki
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
NTT Medical Center Tokyo
Address
5-9-22Higashi Gotanda, Shinagawa, Tokyo
Tel
03-3448-6111
hiroyama90@hotmail.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
Tokyo
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066028
