UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062294 |
|---|---|
| Receipt number | R000071052 |
| Scientific Title | A Single-Center Prospective Exploratory Study Evaluating the Utility of a Novel Biopsy Needle for Endoscopic Ultrasound-Guided Tissue Acquisition of Upper Gastrointestinal Subepithelial Lesions Measuring 10-19 mm |
| Date of disclosure of the study information | 2026/07/21 |
| Last modified on | 2026/07/21 22:06:51 |
* 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
A Single-Center Prospective Exploratory Study Evaluating the Utility of a Novel Biopsy Needle for Endoscopic Ultrasound-Guided Tissue Acquisition of Upper Gastrointestinal Subepithelial Lesions Measuring 10-19 mm
Acronym
A Single-Center Prospective Exploratory Study Evaluating the Utility of a Novel Biopsy Needle for Endoscopic Ultrasound-Guided Tissue Acquisition of Upper Gastrointestinal Subepithelial Lesions Measuring 10-19 mm
Scientific Title
A Single-Center Prospective Exploratory Study Evaluating the Utility of a Novel Biopsy Needle for Endoscopic Ultrasound-Guided Tissue Acquisition of Upper Gastrointestinal Subepithelial Lesions Measuring 10-19 mm
Scientific Title:Acronym
A Single-Center Prospective Exploratory Study Evaluating the Utility of a Novel Biopsy Needle for Endoscopic Ultrasound-Guided Tissue Acquisition of Upper Gastrointestinal Subepithelial Lesions Measuring 10-19 mm
Region
| Japan |
Condition
Condition
Gastrointestinal subepithelial lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of endoscopic ultrasound-guided tissue acquisition (EUS-TA) using a novel biopsy needle (SecureFlex) for 10-19 mm upper gastrointestinal subepithelial lesions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of EUS-TA
Key secondary outcomes
The amount of stereomicroscopically visible white cores
Diagnostic accuracy of the cutoff value for stereomicroscopically visible white cores
Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic ultrasound-guided tissue acquisition (EUS-TA) using a novel biopsy needle (SecureFlex)
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
1) Patients with 10-19 mm subepithelial lesions (SELs) originating from the muscularis propria layer of the upper gastrointestinal tract (esophagus, stomach, or duodenum), diagnosed by prior endoscopic ultrasound (EUS), in whom pathological diagnosis is required for determining the treatment strategy.
2) Patients who wish to undergo histopathological tissue diagnosis.
3) Patients aged >=18 years who have provided written informed consent to participate in this study.
Key exclusion criteria
1) Patients with coagulopathy or a bleeding tendency.
2) Patients with severe psychiatric disorders.
3) Pregnant patients.
4) Patients with a medical condition that makes sedation difficult or inappropriate.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami-ku Sagamihara Kanagawa, Japan
TEL
81-42-778-8111
m.wata@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami-ku Sagamihara Kanagawa, Japan
TEL
81-42-778-8111
Homepage URL
m.wata@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Kitasato University School of Medicine
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
Institutional Ethics Committee of Kitasato University
Address
1-15-1 Kitasato Minami-ku Sagamihara Kanagawa, 252-0374 Japan
Tel
81-42-778-7756
rinri@med.kitasato-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
| 2026 | Year | 07 | Month | 21 | 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
| 2026 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2028 | Year | 01 | 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
| 2026 | Year | 07 | Month | 21 | Day |
Last modified on
| 2026 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071052
