UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062510 |
|---|---|
| Receipt number | R000071547 |
| Scientific Title | Embolization of Persistent Endoleaks after EVAR with High Concentration Glucose Solution: A Pilot Study |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/08/07 13:59:24 |
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Basic information
Public title
Embolization of Persistent Endoleaks after EVAR with High Concentration Glucose Solution: A Pilot Study
Acronym
EEHGS: A pilot study
Scientific Title
Embolization of Persistent Endoleaks after EVAR with High Concentration Glucose Solution: A Pilot Study
Scientific Title:Acronym
EEHGS: A pilot study
Region
| Japan |
Condition
Condition
Abdominal Aortic Aneurysm
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pilot Study on the Safety of High Concentration Glucose Solution Embolization for Type II Endoleaks after EVAR
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Safety of High Concentration Glucose Solution Embolization for Type II Endoleaks after EVAR.
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
| Medicine | Maneuver |
Interventions/Control_1
Embolization of Endoleaks after EVAR with High Concentration Glucose Solution
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Written informed consent obtained from the patient or legal guardian.
2)Expected survival of at least 18 months from the date of enrollment.
3)Prior EVAR for abdominal aortic aneurysm, with dynamic CT or MRI demonstrating contrast enhancement within the aneurysm sac suggestive of an endoleak.
4)Aneurysm sac enlargement, even if contrast enhancement is not clearly observed.
5)Suspected Type 2 or Type 5 endoleak.
6)Open surgical repair is contraindicated or the patient refuses open surgery.
7)Preserved major organ function, defined as:
1. WBC over 2500/mm3 2. Platelets over 50000/mm3 3. Hemoglobin over 6.0 g/dL 4. Serum creatinine less than 3.0 mg/dL 5. Total bilirubin less than 3.0 mg/dL
Key exclusion criteria
1)Age over 90 years.
2)Presence of severe comorbidities, including:
1. Uncontrolled malignancy 2. Severe pulmonary disease 3. Severe cardiac disease 4. Severe hepatic or renal dysfunction
5. Severe active inflammation or infection 6. Poorly controlled diabetes mellitus 7. Immunosuppressed state such as ongoing steroid therapy 8. Any other condition judged by the investigator to significantly interfere with study procedures
3)Inability to maintain prone or lateral decubitus position.
4)Inability to undergo MRI examination.
5)Inability to safely puncture the abdominal aortic aneurysm sac.
6)Clinically significant bleeding tendency (PT INR over 2.0).
7)Ongoing use of antiplatelet, thrombolytic, or anticoagulant agents that cannot be temporarily discontinued.
8)Patients undergoing dialysis.
9)Type 1,3,4 endoleaks. Because these types may be diagnosed only after angiography performed post registration, exclusion after enrollment is permitted. Excluded cases will not be counted toward the total enrollment number.
10)Pregnancy or possibility of pregnancy.
11)Determination by the attending physician that the patient is unsuitable for participation in this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Fujiwara |
Organization
Kawasaki Medical School General Medical Center
Division name
Radiology
Zip code
7008505
Address
Nakasange, Okayama Kita-ku, Okayama
TEL
0862252111
hirofujiwar@gmail.com
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Fujiwara |
Organization
Kawasaki Medical School General Medical Center
Division name
Radiology
Zip code
7008505
Address
Nakasange, Okayama Kita-ku, Okayama
TEL
0862252111
Homepage URL
hirofujiwar@gmail.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
Hiroyasu Fujiwara
Funding Source
Organization
Other
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
Kawasaki Medical School General Medical Center
Address
Nakasange, Okayama Kita-ku, Okayama
Tel
0862252111
hirofujiwar@gmail.com
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 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 01 | 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 | 08 | Month | 07 | Day |
Last modified on
| 2026 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071547
