A Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4).

Inclusion Criteria:

• Have a BMI ≥ 27;

• Be male or female, between 18 and 65 years of age, inclusive;

• Have a history of excess weight (BMI ≥ 27 kg/m2) for at least 2 years and havefailed more conservative weight-reduction alternatives, such as supervised diet,exercise and behavioral modification programs;

• Be willing to commit to a long-term low calorie (1000-1500 calories/day) superviseddiet;

• Have reasonable weight loss expectations (accept a goal of losing up to 15% of bodyweight after 52 weeks);

• Be able to follow requirements outlined in the protocol, including complying withthe visit schedule and behavioral modification program, and willing to undergoprotocol-specific procedures, e.g., endoscopy, local sedation, general anesthesia,upper gastrointestinal radiography (UGI), electrocardiography (EKG), gastricmotility testing, and/or clinical laboratory testing, and must be willing to takeprescribed proton pump inhibitors (PPIs);

• Be able to provide written informed consent;

• Have successful completion of the pre-placement screening and educational programssupporting that the subject is an appropriate study candidate;

• Be willing to use contraception (e.g., birth control pills, condoms, abstinence) andavoid pregnancy during the study if female of child-bearing potential.

Exclusion Criteria:

• Previous history of esophageal, gastric or duodenal surgery, any bariatric surgery,any hiatal hernia surgery, bowel obstruction surgery, adhesive peritonitis, and/orhiatal hernia > 4 cm;

• A history of myocardial infarction in the previous 6 months: New York HeartAssociate (NYHA) Class III or IV (heart failure) or cardiac arrhythmia (e.g. atrialfibrillation);

• History or symptoms of varices, bowel obstruction, congenital or acquired GIanomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal,hepatic, and/or pulmonary disease;

• History or symptoms of inflammatory bowel disease, such as Crohn's disease;

• History of unstable thyroid disease;

• History of uncontrolled gastro-esophageal reflux;

• Type I diabetes;

• History of dysphagia, esophageal stricture or esophageal food impaction;

• Poor general health, in the opinion of the Placing and/or Evaluating Investigator,or presence of a specific medical condition that would increase the risks associatedwith endoscopy and/or placement of the Spatz4;

• Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary arterydisease.

• Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD);

• Specific diagnosed genetic or hormonal cause for obesity such as Prader Willisyndrome

• History or symptoms of esophageal or GI motility disorders (e.g., gastroparesis,achalasia, diffuse esophageal spasm) or symptoms of esophageal stricture;

• Ongoing treatment with anticoagulants, steroids, aspirin > 100 mg, non-steroidalanti-inflammatory drugs (NSAIDS), or other medications known to be gastricirritants, and inability or unwillingness to discontinue the use of theseconcomitant medications;

• Evidence of untreated psychiatric or eating disorders, such as major depression,schizophrenia, substance abuse;

• Pregnancy, breast-feeding, or intention of becoming pregnant during the study (iffemale of childbearing potential);

• A condition, or is in a situation, which in the Evaluating and/or PlacingInvestigator's opinion may put the subject at significant risk, may confound thestudy results, or may interfere significantly with the subject's participation inthe study.