UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054070 |
|---|---|
| Receipt number | R000061403 |
| Scientific Title | A multi-center open-label randomized controlled trial to evaluate the efficacy of the Mantis Clip for defect closure following colorectal endoscopic submucosal dissection |
| Date of disclosure of the study information | 2024/04/08 |
| Last modified on | 2024/04/08 19:26:27 |
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Basic information
Public title
A multi-center open-label randomized controlled trial to evaluate the efficacy of the Mantis Clip for defect closure following colorectal endoscopic submucosal dissection
Acronym
A multi-center open-label randomized controlled trial to evaluate the efficacy of the Mantis Clip for defect closure following colorectal endoscopic submucosal dissection
Scientific Title
A multi-center open-label randomized controlled trial to evaluate the efficacy of the Mantis Clip for defect closure following colorectal endoscopic submucosal dissection
Scientific Title:Acronym
A multi-center open-label randomized controlled trial to evaluate the efficacy of the Mantis Clip for defect closure following colorectal endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
Colorectal neoplasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To address the efficacy of the Mantis clip for defect closure after colonoscopic endoscopic submucosal dissection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The complete defect closure rate
Key secondary outcomes
- Closure time (min)
- Closure speed (mm2/min)
- Post-ESD complication rate (delayed bleeding, delayed perforation, Post-ESD coagulation syndrome) (%)
- The rate of complication related to closure procedure (%)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
MANTIS Clip closure group: Defect closure after colorectal ESD is performed using Mantis Clip and conventional clip.
Interventions/Control_2
Conventional clip closure group: Defect closure after colorectal ESD is performed using conventional clips alone.
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
1. Lesions meeting the indication criteria for colorectal ESD
2. Lesions with a diameter estimated to be 20 mm or larger by preoperative endoscopic evaluation
Key exclusion criteria
- Patients who do not give consent for the study
- Patients with lesions involving anal verge
- Patients with lesions involving terminal ileum
- Patients undergoing endoscopic resection for multiple lesions
- Patients with lesions more than 2/3 of the lumen
- Patients with nickel hypersensitivity
- Patients who are not managed according to guidelines regarding perioperative withdrawal of antithrombotic therapy
- Patients with coagulopathy at high risk of bleeding
- Patients who are pregnant
- Patients who are judged unsuitable for participation by the doctors
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Tada |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
1058471
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL
0334331111
naoya6295@outlook.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Tada |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
1058471
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL
0334331111
Homepage URL
naoya6295@outlook.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
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
The Jikei University School of Medicine
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
Tel
0334331111
rinri@jikei.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
| 2024 | Year | 04 | Month | 08 | 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
| 2024 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 03 | 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 | 04 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061403
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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