UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031420 |
|---|---|
| Receipt number | R000035876 |
| Scientific Title | Clip on Clip Closure Method (CCCM) for mucosal defect after colorectal endoscopic submucosal dissection: a prospective study |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2019/02/23 09:06:49 |
* 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
Clip on Clip Closure Method (CCCM) for mucosal defect after colorectal endoscopic submucosal dissection: a prospective study
Acronym
CCCM for mucosal defect after colorectal endoscopic submucosal dissection
Scientific Title
Clip on Clip Closure Method (CCCM) for mucosal defect after colorectal endoscopic submucosal dissection: a prospective study
Scientific Title:Acronym
CCCM for mucosal defect after colorectal endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
Early colorectal cancer and colorectal adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety of Clip on Clip Closure Method (CCCM) in mucosal defect closure after ESD of colorectal adenoma and early colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Evaluate whether mucosal defect after ESD is closed by Clip on Clip Closure Method using conventional clip.
Key secondary outcomes
Number of CCCM, procedures time of CCCM, number of CCCM dropouts, mucosal defect closure treatment time, number of clips used for mucosal defect closure, postoperative adverse events.
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
| Device,equipment |
Interventions/Control_1
For mucosal defect after ESD, only conventional clips are used and closed using Clip on Clip Closure 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 colorectal cancer and adenoma suitable for ESD. Cases with written and oral informed consent are included.
Key exclusion criteria
Cases with severe complications are excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Oyamada Jun |
Organization
Ise Red Cross Hospital
Division name
Gastroenterology
Zip code
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 | |
| Middle name | |
| Last name | Nomura Tatsuma |
Organization
Kinan Hospital
Division name
Internal medicine, Gastroenterology
Zip code
Address
4750 Atawa, Mihama, Minamimuro, Mie 519-5293, Japan
TEL
05979-2-1333
Homepage URL
m06076tn@icloud.com
Sponsor or person
Institute
Ise Red Cross 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
Address
Tel
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
伊勢赤十字病院（三重），市立四日市病院（三重），医療法人山下病院（愛知）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 01 | 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
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | 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
| 2018 | Year | 02 | Month | 22 | Day |
Last modified on
| 2019 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035876
