UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053484 |
|---|---|
| Receipt number | R000061046 |
| Scientific Title | Prospective Study on Esophageal and Gastric Endoscopic Submucosal Dissection Using a New Thin Scope EG-840TP |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/01/30 18:37:43 |
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Basic information
Public title
Prospective Study on Esophageal and Gastric Endoscopic Submucosal Dissection Using a New Thin Scope EG-840TP
Acronym
Study on ESD Using a New Thin Scope
Scientific Title
Prospective Study on Esophageal and Gastric Endoscopic Submucosal Dissection Using a New Thin Scope EG-840TP
Scientific Title:Acronym
Study on EG-840TP-ESD
Region
| Japan |
Condition
Condition
superficial carcinoma of the esophagus or early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of esophageal and gastric ESD with EG-840TP.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients who complete treatment without changing from EG-840TP to another scope (completion rate).
Key secondary outcomes
Treatment time per site, number of hemostats used, en bloc resection rate, en bloc complete resection rate, scope questionnaire, sedative and analgesic doses during ESD, incidence of adverse events (perforation, posterior hemorrhage).
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing esophageal or gastric ESD at our hospital.
Patients who have given their consent to participate in the study on paper.
Patients over 18 years old.
Key exclusion criteria
Patients who are allergic to propofol, pentazocine, or lidocaine.
Patients who are allergic to propofol, pentazocine, or lidocaine.
Pregnant or lactating patients.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Sato |
Organization
Sendai Open Hospital, Sendai Medical Center
Division name
Department of Gastrointestinal and Hepatobiliary Medicine
Zip code
983-0824
Address
5-22-1 Tsurugaya, Miyagino-ku, Sendai-shi, Miyagi
TEL
022-252-1111
hrkst31016@openhp.or.jp
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Kurita |
Organization
Sendai Open Hospital, Sendai Medical Center
Division name
Medical office
Zip code
983-0824
Address
5-22-1 Tsurugaya, Miyagino-ku, Sendai-shi, Miyagi
TEL
022-252-1111
Homepage URL
hisho2@openhp.or.jp
Sponsor or person
Institute
Sendai Open Hospital, Sendai Medical Center
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
Sendai Open Hospital, Sendai Medical Center
Address
5-22-1 Tsurugaya, Miyagino-ku, Sendai-shi, Miyagi
Tel
022-252-1111
k.tochikubo@openhp.or.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 | 02 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A single-center, single-arm, prospective cohort study.This study will include patients who will undergo esophageal or gastric ESD at our hospital between February 1, 2024 and January 31, 2025, who are at least 18 years old and whose consent has been obtained on paper.
Management information
Registered date
| 2024 | Year | 01 | Month | 30 | Day |
Last modified on
| 2024 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061046
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
