UMIN-CTR Clinical Trial

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
Email	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
Email	sasaki26314@yahoo.co.jp

Sponsor
Institute	Sapporo Orthopaedics and Cardiovascular Hospital
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027007