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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025616
Receipt No. R000029203
Scientific Title The validation study of the efficacy of surgical and endoscopic procedures for adiposity and related comorbidity.
Date of disclosure of the study information 2017/01/23
Last modified on 2019/09/11

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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

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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