UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054997 |
|---|---|
| Receipt number | R000062806 |
| Scientific Title | Gas-free immersion system for rapid hemostasis during gastric endoscopic submucosal dissection: A prospective feasibility study |
| Date of disclosure of the study information | 2024/07/18 |
| Last modified on | 2026/01/17 09:56:05 |
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Basic information
Public title
Gas-free immersion system for rapid hemostasis during gastric endoscopic submucosal dissection: A prospective feasibility study
Acronym
GFI for rapid hemostasis during gastric ESD: A prospective feasibility study
Scientific Title
Gas-free immersion system for rapid hemostasis during gastric endoscopic submucosal dissection: A prospective feasibility study
Scientific Title:Acronym
GFI for rapid hemostasis during gastric ESD: A prospective feasibility study
Region
| Japan |
Condition
Condition
Early gastric tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study was to assess the feasibility of endoscopic submucosal dissection (ESD) using a gas-free immersion system under saline-immersion conditions, in order to evaluate prospective and to reveal whether rapid haemostasis can be achieved.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of bleeding during ESD, total duration of bleeding, duration of resection, diameter of resected lesion, speed of dissection,
Key secondary outcomes
Post-operative adverse events (bleeding, perforation, post-ESD electrocoagulation syndrome)
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
ESD is performed in immersion using a gas-free immersion system.
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
Subjects who adequately understand the study and give written consent will be included in the study. Subjects with adenomas or suspected early-stage intramucosal carcinomas of the gastrointestinal tract for which ESD is indicated according to the treatment guidelines for each gastrointestinal tract will be included.
Key exclusion criteria
Lesions extending into the esophagus or duodenum
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tatsuma |
| Middle name | |
| Last name | Nomura |
Organization
Suzuka General Hospital
Division name
Gastroenterology
Zip code
5138630
Address
Suzuka General Hospital, 1275-53, Yamanohana, Yasuduka, suzuka, Mie,
TEL
8159-382-1311
m06076tn@icloud.com
Public contact
Name of contact person
| 1st name | Tatsuma |
| Middle name | |
| Last name | Nomura |
Organization
Suzuka General Hospital
Division name
Gastroenterology
Zip code
5138630
Address
Suzuka General Hospital, 1275-53, Yamanohana, Yasuduka, suzuka, Mie,
TEL
8159-382-1311
Homepage URL
m06076tn@icloud.com
Sponsor or person
Institute
Suzuka General 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
Suzuka General Hospital Clinical Research Ethics Committee
Address
Suzuka General Hospital, Suzuka, Mie, Japan1275-53, yamanohana, yasuzuka, suzuka, Mie 513-8630, Japa
Tel
059-382-1311
somu@sch.miekosei.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 | 07 | Month | 18 | 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
| 2024 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | 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 | 07 | Month | 17 | Day |
Last modified on
| 2026 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062806
