The USGI Medical ESSENTIAL Study for Weight Loss

Inclusion criteria

• ✓. Provide written informed consent.
• ✓. Be male or female subjects between the ages of 22-60 years.
• ✓. If female, be either post-menopausal, surgically sterile or agree to practice birth control during year of study and have negative serum HCG at screening and baseline.
• ✓. Have a Body Mass Index (BMI) of ≥30 and \<35 with at least one non-severe co-morbid obesity related condition or a BMI ≥ 35 and \< 40 with or without a non-severe obesity related co-morbid condition, where a severe co-morbid condition is defined as severe if symptoms cause severe discomfort, performance of daily activities is compromised, and/or condition is not entirely controlled with prescription drug therapy.
• ✓. Have had no significant weight change (+/- 5% of total body weight) in last 6 months.
• ✓. Have an American Society Anesthesiologists-PS score ≤ 2 (Appendix III).
• ✓. Agrees not to have any additional weight loss interventional procedures, liposuction, or take any over the counter or prescription weight loss medication for 24 months following study enrollment.
• ✓. Have not taken any prescription or over the counter weight loss medications for at least 6 months and agrees not to utilize for 12 months following study enrollment.