Endoscopic Suturing of the Gastric Pylorus to Delay Gastric Emptying and Treat Obesity

The purpose of this study is to evaluate the safety, technical feasibility, and effectiveness
of a endoscopic guided treatment for obesity - endoscopic pyloric suturing. The hypothesis
and rationale for the study is that gastric pyloric restriction will cause early and
prolonged satiety which will lead to decreased food intake and eventual weight loss. Both
safety and efficacy of endoscopic pyloric suturing has been demonstrated in an animal model.

Screening of the participant is done 6-8 weeks prior to the procedure. Screening includes
general history and physical examination, biochemical and laboratory analysis and informed
consent. A baseline patient visit is performed 4-6 weeks prior to the procedure. The baseline
visit involves a four hour gastric emptying scan in order to determine the rate of emptying
of the stomach, the regional emptying of the upper and lower stomach, and the frequency and
amplitude of contractions in the lower stomach. The baseline visit also includes nutritional
counselling.

The procedure is performed in the endoscopy suite as an outpatient procedure. Patient will be
prepped following usual practices and placed in a left lateral decubitus position. Following
induction of sedation or anesthesia by the anesthesia provider, a complete endoscopic
evaluation of the esophagus, stomach and jejunum following standard medical practices will be
performed. The endoscope with mounted suturing device is advanced through an over-tube to the
antrum and assess target area for stitch placement (physician will select appropriate target
site in relation to participant's anatomy). The number of sutures required will vary for each
procedure based on the size of the pylorus; however, it is thought that one or two sutures
across the pylorus will be sufficient enough to achieve a functional restriction of the
pylorus.

Participants will to be observed for a minimum of 1 hour following the procedure to monitor
for adverse events. Patients will be recommended to take the following medications in order
to minimize complications following pyloric suturing procedure; Proton Pump Inhibitor
Omeprazole 40 mg recommended daily for 1 week prior to planned procedure date - and 40 mg
twice daily after the procedure, Anti-Emetic -- Reglan or Zofran at the end of procedure and
as needed after the procedure, and Scopalamine Patch to prevent nausea and vomiting.

All participants will be required to adhere to the follow-up schedule outlined below unless
they have withdrawn their consent or died. The reason(s) the participant is not followed will
be documented by the investigator. Follow-up for all participants will include a telephone
contact at 1 and 18 weeks and clinic visits at 2,4, 8,10,12 and 24 weeks. At the 4 week
visit, the participants will undergo a repeat four hour gastric emptying scan. At 3 months
after the procedure participants will undergo repeat endoscopy to access the stomach and the
suture site.

Inclusion Criteria:

- Age 18- 65

- Male or female participants with a BMI >30 and < 45

- Female participants of childbearing age should not be pregnant, must have a negative
serum or urine test and agree to use birth control for duration of the study.

- Participant did not undergo previous Roux-en-Y bypass with the gastric pouch limited
to the cardia

Exclusion Criteria:

- Allergic to eggs or egg products, wheat, Gluten or Prolamins.

- currently on life saving oral medications

- Participants allergic to Scopolamine

- Participants allergic to botulinum toxin

- Participants who are currently on oral medications for their serious medical
conditions.

- Recent tobacco cessation (within 3 months prior to planned enrollment) or plan to quit
smoking during the study

- Infection anywhere in the body at time of procedure or other diseases that would make
participant unsuitable for treatment (e.g., systemic disease, HIV, malignancy,
autoimmune disease, etc.)

- patients who cannot undergo endoscopy

- Active disease of the gastrointestinal tract including esophageal inflammation,
varices or ulceration, or specific inflammation such as Crohn's disease or ulcerative
colitis

- Esophageal or cricopharyngeal narrowing or stricture; distorted esophagus or known
esophageal pouch

- Heavily scarred, malignant, or poor quality (e.g., friable or overly compliant) tissue
in area to be sutured

- Severe eating disorders such as bulimia (use of purgatives/laxatives) or anorexia
nervosa

- Significant movement limitations of lower extremities (e.g., cannot walk without the
use of, or assistance from, a brace, cane, crutch, another person, prosthetic device,
wheelchair, or other assistive device or is severely limited in their ability to walk
due to an arthritic, neurological, or orthopedic condition)

- Recently (within previous 3 months) prescribed or initiated therapy with medication(s)
known to cause significant weight gain or likely to require treatment with such
medication(s) during the study OR is currently taking or has taken within the previous
3 months prescription or over-the-counter weight loss medications (e.g., medications
and/or supplements containing ephedrine, phenylpropanolamine, amphetamines, etc.).
Additionally, use of such medications and weight loss/appetite suppressing dietary
supplements are prohibited during the course of the trial including the screening
period

- Participant has history of significant cardiovascular or pulmonary disease (e.g.,
myocardial infarct, unstable angina, congestive heart failure, pulmonary edema or
COPD) or other significant cerebrovascular disease (e.g., stroke)

- Not a candidate for general or conscious/moderate sedation

- Participant is on anticoagulant therapy (heparin, coumadin, Plavix, Ticlid, etc.) and
must discontinue use of 325 mg aspirin within 6 weeks of procedure

- Active substance abuse (e.g., alcohol or drugs). This is done with personal interview
only. No drug tests are being performed to determine the active abuse

- The participant has life expectancy of less than 1 year due to other medical
conditions

- The participant is currently enrolled in another investigational drug or device trial
that has not completed the primary endpoint or that clinically interferes with this
trials study endpoints

- Patients having Diabetes