UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040991 |
|---|---|
| Receipt number | R000046806 |
| Scientific Title | Safety study of endoscopic intragastric balloon placement for obese patients with endocrine and metabolic diseases |
| Date of disclosure of the study information | 2020/07/02 |
| Last modified on | 2020/07/02 21:53:35 |
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Basic information
Public title
Safety study of endoscopic intragastric balloon placement for obese patients with endocrine and metabolic diseases
Acronym
Safety study of endoscopic intragastric balloon placement for obese patients with endocrine and metabolic diseases
Scientific Title
Safety study of endoscopic intragastric balloon placement for obese patients with endocrine and metabolic diseases
Scientific Title:Acronym
Safety study of endoscopic intragastric balloon placement for obese patients with endocrine and metabolic diseases
Region
| Japan |
Condition
Condition
Obese patients with any of the metabolic disorders (diabetes, hypertension, dyslipidemia are diagnosed according to the diagnostic criteria of the Japan Diabetes Society, The Japanese Society of Internal Medicine, Japanese Atherosclerotic Disease Prevention Guidelines)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Before and after endoscopic intragastric balloon placement, we analyze the quantitative evaluation of diabetes, hypertension, and NASH subtypes over time, in addition to the presence or absence of accidents.
The primary endpoint is the safety of endoscopic intragastric balloon placement.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of endoscopic intragastric balloon placement
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
N/A
Key exclusion criteria
N/A
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Kaneko |
Organization
Kanazawa university
Division name
Gastroenterology
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa City, Ishikawa Prefecture
TEL
076-265-2235
tohayashi@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Hayashi |
Organization
Kanazawa university
Division name
Gastroenterology
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa City, Ishikawa Prefecture
TEL
076-265-2235
Homepage URL
tohayashi@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa university
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa University Advanced Medical Center
Address
13-1 Takaramachi, Kanazawa City, Ishikawa Prefecture
Tel
076-265-2000
hpsangak@adm.kanazawa-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
| 2020 | Year | 07 | Month | 02 | 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
| 2019 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Major eligibility criteria: BMI27.5 kg/m2 or more with metabolic abnormality
Timing of registration: After obtaining consent for treatment
Randomization timing: No randomization
Number of cases: 10 cases
Registration period: March 31, 2022 from the date of approval
Outline of treatment contents: Place the balloon in the stomach endoscopically.
Treatment period: 1 day
Effectiveness judgment period: 2 weeks, 1 month, 3 months, 6 months after indwelling of the balloon in the stomach
Trial Phase: Phase I
Randomization: None
Specific clinical research or non-specific clinical research: Specific clinical research
Management information
Registered date
| 2020 | Year | 07 | Month | 02 | Day |
Last modified on
| 2020 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046806
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
