UMIN-CTR Clinical Trial

Basic information
Public title	The validation study of the efficacy of surgical and endoscopic procedures for adiposity and related comorbidity.
Acronym	The validation study of the efficacy of surgical and endoscopic procedures for adiposity and related comorbidity.
Scientific Title	The validation study of the efficacy of surgical and endoscopic procedures for adiposity and related comorbidity.
Scientific Title:Acronym	The validation study of the efficacy of surgical and endoscopic procedures for adiposity and related comorbidity.
Region	Japan

Condition
Condition	Adiposity and related comorbidity.
Classification by specialty	Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Validate a weight-loss-effect of bariatric surgery and endoscopic intragastric balloon placement for obese patients that are resistant to medical therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Absolute weight loss and excess-weight loss late.
Key secondary outcomes

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	Maneuver
Interventions/Control_1	Initially, all patients undergo are performed endoscopic intragastric balloon placement. After 6 moths from performing endoscopic intragastric balloon placement, patients that meet the following inclusion criteria will be performed bariatric surgery (ex. Laparoscopic Adjustable Gastric Banding, Laparoscopic Roux en Y gastric bypass and Laparoscopic Sleeve Gastrectomy).
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1. Body Mass Index > 35 2. Existence of disability in daily life. 3. Resistant to the medical therapy. 4. Have an ability to understand this trial and strong preference to enroll in this trial. - Inclusion criteria for bariatric surgery - After 6 moths from performing endoscopic intragastric balloon placement, patients that meet 1. and 2.
Key exclusion criteria	1) Poor response to the previous medical therapy because of the patients' poor compliance. 2) Unwilling to undergo surgery. 3) Obese due to psychiatric disorders. 4) Have cosmetic purpose to enroll in this trial.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hirofumi Middle name Last name Kawakubo
Organization	Keio University School of Medicine
Division name	Department of Surgery
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku, Tokyo, JAPAN
TEL	03-3353-1211
Email	hkawakubo@z3.keio.jp

Public contact
Name of contact person	1st name Hirofumi Middle name Last name Kawakubo
Organization	Keio University School of Medicine
Division name	Department of Surgery
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku, Tokyo, JAPAN
TEL	03-3353-1211
Homepage URL
Email	hkawakubo@z3.keio.jp

Sponsor
Institute	Department of Surgery, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Department of Surgery, Keio University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keio University School of Medicine, Ethics Committee
Address	35 Shinanomachi, Shinjuku, Tokyo, JAPAN
Tel	03-5363-3503
Email	med-rinri-jimu@adst.keio.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	2017 Year 01 Month 23 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	Terminated
Date of protocol fixation	2009 Year 11 Month 18 Day
Date of IRB	2009 Year 11 Month 18 Day
Anticipated trial start date	2009 Year 11 Month 18 Day
Last follow-up date	2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 11 Day
Last modified on	2019 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029203