ENDURE II: AN INVESTIGATIVE, PROSPECTIVE, NON-RANDOMIZED, MULTI-CENTER STUDY TO ASSESS THE SAFETY AND EFFECTIVENESS OF A NOVEL GASTRIC RESTRICTIVE DEVICE, CALLED THE RESHAPE VEST*, IN PEOPLE WHO ARE OBESE.

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 < 40 kg/m2 may be enrolled in the presence of at
least one obesity-related comorbidity.
3. Failed one or more conservative weight-reduction alternative(s), such
as supervised diet, exercise, and behavior modification program(s)
within the last five years;
4. Able to comprehend, follow and give signed informed consent;
5. Reside within a reasonable distance from the Investigator's treating
office and able and willing to travel to the Investigator's office to
complete all routine follow-up visits;
6. Ability to comply with all study requirements for the duration of the
study, as outlined in the protocol, willing to submit to significant
lifestyle changes that include diet, eating and exercise habits for the
duration of the clinical study;
7. Females of childbearing potential (FOCBP) must be willing to avoid
pregnancy throughout the duration of the study, including follow-up,
and must agree to the following:
o have a negative serum pregnancy test at screening,
o negative urine pregnancy test day of implant,
o and inform the investigator immediately if the subject becomes
pregnant;
8. Willing to abstain from illegal drugs, including marijuana and tobacco
(all forms) during study participation;
9. Willing to limit alcohol consumption following the opinion of the
Science Group of the European Alcohol and Health Forum of the
European Commission;
10. Have a stable concomitant medication regimen at the time of screening
to mitigate drug induced weight fluctuations. A stable regimen is
defined as 90 days without the introduction of or change in medication;
11. Agrees to refrain from any type of reconstructive surgery/procedures
that would affect body weight (such as abdominal lipoplasty or
liposuction, mammoplasty, removal of excess skin or cool sculpting) during the
follow-up period after placement of the LGV

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) < 45 ml/min/1.73 m2, ALT or AST > 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 <11.0 g/dl,
for males <12.0 g/dl;
15. Abnormal blood cell indices deemed to be clinically significant;
16. Diabetes requiring insulin at baseline (Type 1 or uncontrolled Type 2
defined as an HbA1c >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. Chronic use of Non Steroid Anti-Inflammatory Drugs (NSAID) which is defined
as daily use for greater than one month (low dose aspirin 81mg daily is
acceptable);
27. History or presence of malignancy such as cancer within the last five years
with the exception of successfully treated non-melanoma skin cancer;
28. Any condition that, in the opinion of the Investigator, would compromise
the well-being of the subject or the study or prevent the subject from meeting
or performing study requirements (e.g., chronic pancreatitis, serious organic
disease which make them poor surgical candidates, chronic infection, severe
cardiopulmonary disease).