The USGI Medical ESSENTIAL Study for Weight Loss

Inclusion Criteria:

1. Provide written informed consent.

2. Be male or female subjects between the ages of 22-60 years.

3. 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.

4. 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.

5. Have had no significant weight change (+/- 5% of total body weight) in last 6 months.

6. Have an American Society Anesthesiologists-PS score ≤ 2 (Appendix III).

7. 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.

8. 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.

9. Be willing to cooperate with post-operative dietary recommendations and assessment
tests.

10. Reside within a reasonable distance from the Investigator's treating office (~50
miles) and able and willing to travel to the Investigator's office to complete all
routine follow-up visits.

Exclusion Criteria:

1. History of (or intra-operative evidence of) prior bariatric, gastric or esophageal
surgery.

2. Esophageal stricture or other anatomy and/or condition that could preclude passage of
endolumenal instruments.

3. Severe gastro-esophageal reflux disease (GERD), defined as symptoms that cause
subject severe discomfort, compromise performance of daily activities, and/or
condition is not entirely controlled with prescription drug therapy.

4. Large hiatal hernia (>3 cm) by history or as determined by pre-randomization
endoscopy.

5. Pancreatic insufficiency/disease.

6. Active gastric erosions or gastric/duodenal ulcer.

7. History of gastroparesis or symptoms that would be suggestive of gastroparesis.

8. Pregnancy or plans of pregnancy in the next 12 months.

9. Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 1
month of Visit 1. Intranasal/inhaled steroids are acceptable.

10. History of inflammatory disease of the GI tract; coagulation disorders; hepatic
insufficiency or cirrhosis

11. History or present use of insulin or insulin derivatives for treatment of diabetes

12. Type II Diabetes Mellitus (as defined by HgbA1c >6.5%) for greater than 10 years at
the time of enrollment

13. Quit smoking within the last 6 months at time of enrollment or plans to quit smoking
in the year after enrollment

14. Portal hypertension and/or varices.

15. Gastric outlet obstruction or stenosis.

16. Significant abnormality identified during Visit 2 (randomization visit) with
endoscopy revealing large hiatal hernia, gastric ulcer, gastric erosions, etc.

17. Patient has a history of drug or alcohol abuse or positive at screening for drugs of
abuse.

18. Beck Depression Inventory (Short) Score ≥12 and/or uncontrolled depression after
pre-enrollment psychological and medical assessment.

19. Present or past history of psychosis, bipolar disease, or obsessive compulsive
disorder after pre-enrollment history and medical /psychological assessment.

20. Non-ambulatory or has significant impairment of mobility.

21. Known hormonal or genetic cause for obesity with the exception of treated
hypothyroidism.

22. Participating in another clinical study.

23. Is a relative of investigator or his/her staff, or is employed by investigator or
institution involved in the study.

24. Subjects with a personal history of allergic/anaphylactic reactions including
hypersensitivity to the drugs or materials that will be utilized in the study
procedure.