UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038123 |
|---|---|
| Receipt number | R000042967 |
| Scientific Title | Prospective observational trial for the development of a new treatment for mucosal suture after endoscopic mucosal resection |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2022/03/30 23:12:40 |
* 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
The development of a new treatment for mucosal suture after endoscopic mucosal resection
Acronym
ECL trial
Scientific Title
Prospective observational trial for the development of a new treatment for mucosal suture after endoscopic mucosal resection
Scientific Title:Acronym
ECL trial
Region
| Japan |
Condition
Condition
early state gastrointestinal neoplasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate efficacy and safety of a new endoscopic suture technique after endoscopic resection for early stage gastrointestinal neoplasia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of complete suture
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
EMR
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
1.The patients who undergo ESD for early stage gastrointestinal neoplasia (stomach, duodenum and colon) in our hospital.
2.The patients who accepted to written informed consent on this study.
Key exclusion criteria
1.Without written informed consent.
2.THe patients judged inappropriate for this study by the physicians.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Hashimoto |
Organization
School of Medicine, Niigata University
Division name
Department of Preemptive Medicine for Digestive Diseases and Healthy Active Life
Zip code
951-8510
Address
1-757 Asahimachidori, Chuoku, Niigata, Japan
TEL
+81-25-227-2207
hashim@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Hashimoto |
Organization
School of Medicine, Niigata University
Division name
Department of Preemptive Medicine for Digestive Diseases and Healthy Active Life
Zip code
951-8510
Address
1-757 Asahimachidori, Chuoku, Niigata, Japan
TEL
+81-25-227-2207
Homepage URL
hashim@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
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
Ethics Committee of Niigata University
Address
1-757 Asahimachidori, Chuoku, Niigata, Japan
Tel
025-227-2625
sanonao@adm.niigata-u.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
| 2019 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 26 | Day |
Last modified on
| 2022 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042967
