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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005768
Receipt No. R000006819
Scientific Title Prospective study of laparoscopic adjustable gastric banding with MIDBAND system for morbidly obese patients
Date of disclosure of the study information 2011/06/13
Last modified on 2013/06/15

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Basic information
Public title Prospective study of laparoscopic adjustable gastric banding with MIDBAND system for morbidly obese patients
Acronym Prospective study of LAGB with MIDBAND system for morbid obesity
Scientific Title Prospective study of laparoscopic adjustable gastric banding with MIDBAND system for morbidly obese patients
Scientific Title:Acronym Prospective study of LAGB with MIDBAND system for morbid obesity
Region
Japan

Condition
Condition Patients for whom gastric banding was indicated will be included in the study. Exhaustive and consecutive inclusions of 20 patients will be carried out at Yotsuya Medical Cube with the MIDBAND implant.
Classification by specialty
Surgery in general Gastrointestinal surgery Endocrine surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of the MIDBAND, whose original characteristics looks promising in terms of effectiveness, post-operative comfort, and prevention of complications.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in weight loss (BMI and percentage of excess weight loss)
Key secondary outcomes Change in obesity-related comorbidity status, change in quality of life

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
Device,equipment Maneuver
Interventions/Control_1 Laparoscopic adjustable gastric banding
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1, age over 18
2, resistant to medical management of weight loss
3, BMI over 30kg/m2
4, written consent for the study
Key exclusion criteria (1) Cardiovascular event in the past 6 months. (2) Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease. (3) Cardiac stress test indicating that surgery would not be safe. (4) Pulmonary embolus or thrombophlebitis in the past 6 months. (5) Cancer of any kind unless documented to be disease-free for 5 years. (6) Significant anemia (hemoglobin 1.0 g or
more below normal range) or history of coagulopathy. (7) Serum creatinine 2.0 mg/dl or more. (8) History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection. (9) Gastric or duodenal ulcer in the past 6 months. (10) History of intra-abdominal
sepsis. (11) Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C,
cirrhosis, or inflammatory bowel disease. (12) Currently pregnant or nursing, or planning to become pregnant in the next 2 years. (13) History of alcohol or drug dependency in the past 5 years. (14) Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol. (15)
Presence of any chronic or debilitating disease that would make adherence to the protocol difficult. (16) Exclusions may also be made at the discretion of the attending physician.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Kasama
Organization Yotsuya Medical Cube
Division name Weight Loss and Metabolic Surgery Center
Zip code
Address 7-7 Nibancho, Chiyoda-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yotsuya Medical Cube
Division name Weight Loss and Metabolic Surgery Center
Zip code
Address
TEL
Homepage URL
Email yosuke_seki@hotmail.com

Sponsor
Institute Yotsuya Medical Cube
Institute
Department

Funding Source
Organization MID(Medical Inovation et Developpement, Dardilly, France)
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization France

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 13 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 No longer recruiting
Date of protocol fixation
2011 Year 05 Month 09 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 06 Month 13 Day
Last modified on
2013 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006819

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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