UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023438 |
|---|---|
| Receipt number | R000027007 |
| Scientific Title | A Procedureless Intra-gastric Diet Balloon Capsule |
| Date of disclosure of the study information | 2016/08/05 |
| Last modified on | 2020/02/14 12:37:40 |
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Basic information
Public title
A Procedureless Intra-gastric Diet Balloon Capsule
Acronym
A Swallowable Balloon Capsule for Bariatric Therapy (BCBT)
Scientific Title
A Procedureless Intra-gastric Diet Balloon Capsule
Scientific Title:Acronym
A Swallowable Balloon Capsule for Bariatric Therapy (BCBT)
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general | Gastroenterology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a non-invasive, patient-friendly and simple bariatric therapy for preventing comorbidities due to obesity.
Basic objectives2
Others
Basic objectives -Others
To validate that this method is so efficient as at reducing body weight as conventional intra-gastric bariatric balloons implanted using endoscopic assistance.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Reducing rate of the excess body weight before and after the trial
Key secondary outcomes
1. Reducing the amount of internal fat tissue which will be evaluated by a CT scan before and after the trial.
2. Efficacy of glucose tolerance and hyperlipidemia 16 weeks after ingestion
3.Changes in the microbiota in the gut using 16S rRNA fecal analysis 16 weeks after ingestion
4.Evaluation of adverse reactions
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Two arm cross-over trial
Arm1: A swallowable balloon capsule (volume 400ml filled with CO2) implanted for 4 months in the stomach
Arm2: A placebo balloon capsule ( not inflatable due to holes in it ) is ingested
Interventions/Control_2
4 months later after excreting the first balloon,
Arm1: placebo balloon capsule.
Arm2: real swallowable balloon capsule
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with a BMI more than 30
2.Patients with a BMI between 25 and 30 who have a past history of, or are presently having treatment for diabetes, hyperlipidemia (LDL-C over 200), angina pectoris, cerebral infarction or NASH (Non- alcoholic steatohepatitis).
Key exclusion criteria
1. Patients undergoing insulin therapy or patients with conditions such as chronic heart failure or chronic renal failure, which would make it very difficult for them to improve physical activity levels.
2. Patients who cannot ingest capsules
3. Patients who have a rubber allergy
4. Patients who have their digestive tract altered by surgery or have a high risk of ileus or stenosis due to stricture in the gastrointestinal tract.
5. Patients who have an implant such as a cardiac pace-maker.
6. Patients who will not allow the doctor to perform an endoscopic procedure in an emergency.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Ohta |
Organization
Sapporo Orthopaedics and Cardiovascular Hospita
Division name
Gastroenterology
Zip code
Address
1-2-11-30 Kitano, Kiyota-ku,
TEL
011-881-1100
hideohta@true.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masami Sasaki |
Organization
Sapporo Orthopaedics and Cardiovascular Hospital
Division name
Committee for Clinical Trial and Institutional Review Board
Zip code
Address
1-2-11-30 Kitano, Kiyota-ku, Sapporo, Japan
TEL
011-881-1100
Homepage URL
sasaki26314@yahoo.co.jp
Sponsor or person
Institute
Sapporo Orthopaedics and Cardiovascular Hospital
Institute
Department
Personal name
Funding Source
Organization
Sapporo Orthopaedics and Cardiovascular Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Sapporo Shiroishi Memorial Hospital,
Otaru Ekisaikai Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
札幌整形循環器病院（北海道）、札幌白石記念病院（北海道）、小樽掖済会病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 05 | 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
| 2016 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 01 | Day |
Last modified on
| 2020 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027007
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