UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045134 |
|---|---|
| Receipt number | R000051563 |
| Scientific Title | Evaluation of the usefulness of adrenal vein sampling with balloon occlusion separation technique |
| Date of disclosure of the study information | 2021/08/12 |
| Last modified on | 2021/08/12 12:24:45 |
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Basic information
Public title
Evaluation of the usefulness of adrenal vein sampling with balloon occlusion separation technique
Acronym
Evaluation of the usefulness of adrenal vein sampling with balloon occlusion separation technique
Scientific Title
Evaluation of the usefulness of adrenal vein sampling with balloon occlusion separation technique
Scientific Title:Acronym
Evaluation of the usefulness of adrenal vein sampling with balloon occlusion separation technique
Region
| Japan |
Condition
Condition
primary aldosteronism
Classification by specialty
| Medicine in general | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the examination diagnostic ability of adrenal vein sampling with balloon occlusion separation technique by comparing with conventional adrenal vein sampling method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic Performance of Balloon Vein Occlusion Isolated Adrenal Vein Sampling for Localization of Lesions in Primary Aldosteronism
Key secondary outcomes
Comparison of inspection time
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
In addition to the conventional method of adrenal vein sampling, we will use the balloon vein occlusion isolation adrenal vein sampling method, which separates the venous blood of the right and left adrenal veins using a balloon catheter. We will compare and analyze the results of the two sampling methods, the conventional method and the balloon vein occlusion isolation adrenal vein sampling method, to determine the diagnostic performance of the test.
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 who will undergo adrenal vein sampling for diagnosis of primary aldosteronism localization and who consent to this clinical trial.
Key exclusion criteria
Patients who did not consent to this clinical trial.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Fukunaga |
Organization
Kawasaki Medical Shool
Division name
Department of Radiology, Division of Diagnostic Radiology
Zip code
7010192
Address
577 Matsusima Kurasiki-shi Okayama-ken Japan
TEL
086-462-1111ext.44438
kcnfm627@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Fukunaga |
Organization
Kawasaki medical school
Division name
Department of Radiology, Division of Diagnostic Radiology
Zip code
7010192
Address
577 Matsusima Kurasiki-shi Okayama-ken Japan
TEL
086-462-1111ext.44438
Homepage URL
kcnfm627@yahoo.co.jp
Sponsor or person
Institute
Kawasaki Medical Shool
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical Shool
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 Shool
Address
577 Matsusima Kurasiki-shi Okayama-ken Japan
Tel
086-464-1076
kmsrec@med.kawasaki-m.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
| 2021 | Year | 08 | Month | 12 | 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
| 2021 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2021 | Year | 08 | Month | 12 | Day |
Last modified on
| 2021 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051563
