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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012792
Receipt No. R000014141
Scientific Title Exploratory trial to evaluate safety and efficacy of minimally invasive radiofrequency ablation therapy for primary aldosteronism patients (investigator-initiated clinical trial)
Date of disclosure of the study information 2014/01/08
Last modified on 2017/06/07

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Basic information
Public title Exploratory trial to evaluate safety and efficacy of minimally invasive radiofrequency ablation therapy for primary aldosteronism patients (investigator-initiated clinical trial)
Acronym Exploratory trial of radiofrequency ablation therapy for primary aldosteronism patients
Scientific Title Exploratory trial to evaluate safety and efficacy of minimally invasive radiofrequency ablation therapy for primary aldosteronism patients (investigator-initiated clinical trial)
Scientific Title:Acronym Exploratory trial of radiofrequency ablation therapy for primary aldosteronism patients
Region
Japan

Condition
Condition primary aldosteronism caused by unilateral aldosterone hyper secretion
Classification by specialty
Endocrinology and Metabolism Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of percutaneous radiofrequency ablation therapy for unilateral aldosterone producing adenoma in normalizing aldosterone secretion.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes aldosterone level in serum and 24-hour urine collection 7 days after ablation therapy
Key secondary outcomes 1. Clinical laboratory test
ACTH, cortisol, serum aldosterone, renin activity, ARR, serum TTKG, osmotic pressure and pottasium level, urine osmolality
2. Antihypertensive medication
Dose at screening and 84 days after ablation therapy
3. Ablation effect evaluation by enhanced computed tomography 7 days after treatment.

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
Device,equipment
Interventions/Control_1 CT guided radiofrequency ablation is performed with total power of 4-6kJ for aldosterone producing adrenal adenoma which is proven as unilateral functioning adenoma by adrenal venous sampling.
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 1. Equal or more than 20 years old at the time of informed concent.
2. Agreement with written informed concent.
3. Primary aldosteronism with unilateral functioning macroadenoma with following conditions:
a. CT detectable adenoma without any risky organs on a puncture route.
b. Intervening adipose tissue between target adenoma and adjacent risky organs(pancreas or intestine).
c. Adenoma diameter between 5 and 25mm.
d. Unilateral single functioning macroadenoma with aldosterone hypersecretion proven by adrenal venous sampling.
e. Enough major organic function with following labolatory datas at screening: WBC>=3000/mm3 Plt>=100,000/mm3, Hb>=8.0 g/dl,eGFR>=45mL/min/1.73m2
f. PS=0-2
Key exclusion criteria 1. Pasemaker or ICD implantation
2. Possibilities of malignancy
3. impaired blood clotting with PT-INR>=2.0
4. Possibilities of infection
5. Intolerance to acute blood pressure change:
a. Abdominal aortic aneurysm with diameter of more than 4cm, Thoracic aortic aneurysm with diameter of more than 5cm, Aortic dissection, Cerebral aneurysm >=5mm
b. Impared cardiac function:
Transthoracic US: LVEF<40% or E/E'>15 or BNP>200 pg/mL
c. hypertensive intracranial bleeding without confirmation of hemostasis (should be confirmed by CT for cerebral bleeding within 180 days)
6.Cushing syndrome or paraganglioma
7. Pregnancy or possibility of pregnancy
8. Hystory of iodine allergy
9. Participants of other clinical trial
10. Difficulty in cessation of the drugs which are prohibited in this trial
11. Patients who are judged as in adequate for this trial by the investigators.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kei Takase
Organization Tohoku University Hospital
Division name Department of Diagnostic Radiology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574 Japan
TEL 022-717-7312
Email ktakase@rad.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Takase
Organization Tohoku University Hospital
Division name Department of Diagnostic Radiology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL 022-717-7312
Homepage URL
Email ktakase@rad.med.tohoku.ac.jp

Sponsor
Institute Department of Diagnostic Radiology,Tohoku University Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labor,and Welfare of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor OLYMPUS MEDICAL SYSTEMS CORP.(only device)
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 08 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 Completed
Date of protocol fixation
2013 Year 11 Month 29 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 22 Day
Last follow-up date
2014 Year 11 Month 10 Day
Date of closure to data entry
2015 Year 01 Month 19 Day
Date trial data considered complete
2015 Year 02 Month 23 Day
Date analysis concluded
2016 Year 03 Month 28 Day

Other
Other related information

Management information
Registered date
2014 Year 01 Month 08 Day
Last modified on
2017 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014141

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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