UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050493 |
|---|---|
| Receipt number | R000057493 |
| Scientific Title | Investigation of the feasibility of a new small-diameter therapeutic endoscope for endoscopic submucosal dissection of the esophagogastric junction |
| Date of disclosure of the study information | 2023/03/07 |
| Last modified on | 2025/01/03 13:57:31 |
* 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
Investigation of the feasibility of a new small-diameter therapeutic endoscope for endoscopic submucosal dissection of the esophagogastric junction
Acronym
Investigation of the feasibility of a new small-diameter therapeutic endoscope
Scientific Title
Investigation of the feasibility of a new small-diameter therapeutic endoscope for endoscopic submucosal dissection of the esophagogastric junction
Scientific Title:Acronym
Investigation of the feasibility of a new small-diameter therapeutic endoscope
Region
| Japan |
Condition
Condition
tumors grow from esophagogastric junction
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate the feasibility of new small-diameter endoscopes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Procedural completion rate using the new endoscope
Key secondary outcomes
Histological complete resection rate, adverse event, procedure time,Endoscopic en bloc resection rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients scheduled for endoscopic treatment at this hospital who will be treated with the new narrower diameter treatment endoscope
Key exclusion criteria
Cases in which the patient is incapable of consenting due to being a minor or suffering from dementia
Cases that the doctor in charge considers unsuitable for registration
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University, school of medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Masunaga |
Organization
Keio University School of Medicine
Division name
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
teppei9027ww@keio.jp
Sponsor or person
Institute
Keio Unversity
Institute
Department
Personal name
Funding Source
Organization
None
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2023 | Year | 03 | Month | 07 | 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
| 2023 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the feasibility of a new small-diameter therapeutic endoscope for endoscopic submucosal dissection of the esophagogastric junction.
Management information
Registered date
| 2023 | Year | 03 | Month | 05 | Day |
Last modified on
| 2025 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057493
