UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005768 |
|---|---|
| Receipt number | 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 16:18:14 |
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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
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
yosuke_seki@hotmail.com
Sponsor or person
Institute
Yotsuya Medical Cube
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006819
