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.
Conditions
Interventions
Sponsors
Yotsuya Medical Cube
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria:
Exclusion criteria
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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change in obesity-related comorbidity status, change in quality of life | — |
Primary
| Measure | Time frame |
|---|---|
| Change in weight loss (BMI and percentage of excess weight loss) | — |
Countries
Japan
Outcome results
None listed