Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity

The laparoscopic gastric plication (LGP) is a new restrictive bariatric surgical technique
that has the potential to eliminate the complications associated with other restrictive
procedures (i.e., gastric banding, sleeve gastrectomy) by creating a restriction without the
use of an implant and without performing gastric resection. LGP is notably similar to a
sleeve gastrectomy in that it generates a gastric tube by means of eliminating the greater
curvature but does so without gastric resection.

Inclusion Criteria:

- Age: 18 - 60 years

- BMI 35-39.9 kg/m2 with one or more severe co-morbid conditions or BMI 40-55 kg/m2

- Willingness to comply with dietary restrictions required by the protocol

- History of obesity for at least 5 years

- History of at least 6 months of documented failures with traditional non-surgical
weight loss methods

- Willingness to follow protocol requirements which include: signing the informed
consent form, completing routine follow-up visits for the study duration, and
completing all pre- and post-operative laboratory and diagnostics tests in addition
to the quality of life questionnaire

- If female with childbearing potential, using an appropriate form of contraception

Exclusion Criteria:

- Age less than 18, age greater than 60

- Pregnancy

- History of major depressive disorder or psychosis

- Previous bariatric surgery or previous gastric surgery

- Presence of achalasia

- Any condition that, in the judgment of the investigator, would place a subject at
undue risk, or could potentially compromise the results or interpretation of the
study