Obesity Severe overweight
Conditions
Interventions
The Laparoscopic Gastric Vest (LGV), branded the ReShape Vest*, is a long-term,
silastic, implantable system that is placed around the stomach to encompass the
gastroesophageal junction to the Incis
Sponsors
ReShape Lifesciences
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age * 22 and * 65 years * between 22 and 65 years of age; 2. Obesity class II and III (Body mass index (BMI) * 35 kg/m2 to 55 kg/m2); Subjects with a BMI * 35 to
Exclusion criteria
Exclusion criteria: 1. Genetically-caused obesity, such as Prader-Willi syndrome; or any disease state know to affect weight status such as Cushing*s syndrome, untreated sleep apnea, inadequately treated thyroid disease; 2. History of chronic and/or ongoing clinically significant conditions or disorders of the gastrointestinal (GI) tract, i.e. Gastroparesis and Inflammatory Bowel Diseases such as Ulcerative Colitis and Crohn*s disease; 3. Any abnormal stenosis or obstruction of the GI tract; 4. Significant acute and/or chronic active infection including H. pylori and urinary tract infection; 5. History, or signs and/or symptoms of acid-peptic disease (APD) or gastric or duodenal ulcer; 6. Diagnosis of portal hypertension, cirrhosis and esophageal varices; 7. Presence of renal or liver disease defined as estimated Glomerular Filtration Rate (eGFR) 2x upper limit normal (ULN) or total bilirubin >1.5x ULN; 8. Previous stomach or bowel surgery; 9. Previous bariatric procedure or device including, but not limited to, intragastric balloons within the past twelve months, sleeve gastrectomy, endoluminal suturing and restrictive bands; 10. History of adhesive peritonitis; 11. Presence of a hiatal hernia greater than 3 cm; 12. History of bleeding disorders such as hemophilia; 13. Subjects who are unable to tolerate abstinence from blood thinners, such as warfarin, during the peri-operative period; 14. Anemia defined as either: Hemoglobin (Hb) value for females of 12%) or a significant likelihood of requiring insulin treatment in the following 24 months; 17. History or known allergies to silicone or similar materials; 18. Participation in other investigational study protocols. If a subject has recently completed participation in another drug or device study, the subject must have exited that study at least 90 days prior to being enrolled in this study. If a subject screen failed prior to receiving study intervention the subject may participate in the study; 19. Concomitant use of (or within 90 days of screening), or unwillingness to avoid any use of, weight loss medications, weight loss supplements, weight loss herbal preparations and/or participation in any non-studyrelated organized weight loss program (commercial or medical) at any time during the study; 20. Undergoing chronic steroid or immunosuppressive therapy, defined as use of any oral and/or injectable steroid of any dose within 90 days of screening; 21. Smoking cessation within two years of study entry; 22. Major upper GI abdominal surgery (other than appendectomy, cholecystectomy, c-section); 23. Significant traumatic injury to the abdomen within 90 days prior to enrollment; 24. Subjects or immediate family members (e.g., biological parents, children, grandparents) with a known diagnosis or pre-existing symptoms of autoimmune connective tissue disease such as systemic lupus erythematosus or scleroderma; 25. Current use of medications known to cause metabolic disturbances, such as the antipsychotic agents olanzapine, quetiapine, and type 2 diabetes medication thiazolidinedione (TZD); 26. Chro
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are: - The primary efficacy endpoint is to demonstrate at least 30% excess weight loss (%EWL) at 12 months1 - The primary safety endpoint is to evaluate safety by device and procedure-related serious adverse events by 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: - To evaluate safety by device and procedure-related serious adverse events by 24 months - To demonstrate an efficacy objective of the maintenance of at least 30% EWL at 24 months - To demonstrate at least 40% EWL for at least 40% of subjects compared to baseline at 24 months - To demonstrate at least 50% EWL for at least 35% of subjects compared to baseline at 24 months Additional observations include: - Change in BMI from baseline at months 12 and 24 - Percentage of total weight loss (%TWL) from baseline at months 12 and 24 - Change in neck, arm, waist and hip circumference from baseline at months 1, 3, 6, 9, 12, 18, and 24, and to explant and 1 month post *explant follow up - Length of hospital stay associated with implantation - Procedure time defined from first incision to closure - Change in blood pressure from baseline at months 1, 3, 6, 9, 12, 18, and 24 - Change in quality of life (QOL) (IWQOL-L, SF-12, TFEQ and WPAI:SHP) from baseline at months 6, 12, and 24 - Change in metabolic parameters, cholesterol, glucose, and glycated hemoglobin from baseline at months 6, 12, 18, and 24 - Change in bio-markers associated with Nonalcoholic steatohepatitis (NASH), APRI (AST, PLT), Fib-4 (APRI components plus age, ALT) and NFS (Fib-4 components plus Albumin BMI), from baseline at months 6, 12, 18 and 24. | — |
Countries
Netherlands
Outcome results
None listed