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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040991
Receipt No. 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

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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
Email 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
Email tohayashi@m-kanazawa.jp

Sponsor
Institute Kanazawa university
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046806

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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