| Eligibility |
Inclusion Criteria:
1. Provision of signed and dated informed consent form.
2. Subject agrees to be compliant with study requirements and adhere to post-operative
dietary & exercise recommendations for the duration of the study.
3. Subjects between the ages of 22-65 years.
4. History or failure with non-surgical weight-loss methods.
5. 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/baseline.
6. Have a Body Mass Index (BMI) of = 30 and = 50 kg/m².
7. Absence of current severe systemic disease (including, but not limited to: coronary
artery disease, chronic obstructive pulmonary disease, congestive heart failure,
cancer, and chronic renal disease).
8. Agrees to forego any additional weight loss interventional procedures or liposuction
for 12 months following study enrollment.
9. Have not taken any prescription or over-the-counter weight loss medications in the
last 6 months, with exception of medications used to manage T2D so long as the subject
has been on a stable dose and weight has persisted.
10. Residing within a reasonable distance from the Investigator's treating office (~50
miles) and willing and able 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
endoluminal instruments or procedure execution.
3. Moderate 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 drug therapy.
4. Large hiatal hernia (>3 cm) by history or as determined by pre-enrollment endoscopy.
5. Pancreatic insufficiency/disease.
6. History of gastroparesis or symptoms that would be suggestive of gastroparesis or
generalized dysmotility (e.g., esophago-gastric motility issues and lower esophageal
sphincter abnormalities).
7. Patients who are known to be pregnant or breast-feeding, or plan to become pregnant in
the next 12 months.
8. History of a known diagnosis or pre-existing symptom of rheumatoid arthritis,
scleroderma, system lupus, or other autoimmune connective tissue disorder.
9. Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 6
months of Visit 1. Intranasal/inhaled steroids are acceptable.
10. Unable or unwilling to avoid use of aspirin and/or non-steroidal anti-inflammatory
drugs (NSAIDs), or other medications known to be gastric irritants beginning two weeks
prior to enrollment and throughout the entire study.
11. History of inflammatory disease of the GI tract; coagulation disorders; hepatic
insufficiency or cirrhosis.
12. Active gastric erosion, lesion, or gastric/duodenal ulcer.
13. History of or current platelet or coagulation dysfunction, such as hemophilia.
14. History or present use of insulin or insulin derivatives for treatment of diabetes.
15. Patients with type II diabetes mellitus on oral agents (not injectables) with HgA1c >
9 at the time of enrollment.
16. Active smoker or someone who has been a smoker in the 6 months leading up to the
study.
17. Portal hypertension and/or varices.
18. Patient has a history of drug or alcohol abuse or positive at screening for drug use.
19. Patient is currently using marijuana/cannabis for either medicinal or recreational
use, or has plans to start using over the next 12 months.
20. Present or history of psychosis, bipolar disease, obsessive-compulsive disorder, binge
eating, and/or other eating disorders after pre-enrollment history and medical
/psychological assessment.
21. Beck Depression Inventory (Short) Score = 12, and/or uncontrolled depression after
pre-enrollment psychological and medical assessment.
22. Patient score >2 in any of the identified symptoms in the nausea/vomiting or
bloating/distension domains on the Gastroparesis Cardinal Symptom Index (GCSI).
23. Non-ambulatory or has significant impairment of mobility (i.e. cannot ambulate for 30
minutes).
24. Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH
>5.0 U/ml).
25. Present or history of chronic abdominal pain.
26. Participating in another clinical study that could compromise compliance with the
POSE2.0 study (must be cleared with investigator and USGI Medical).
27. Subjects with a personal history of allergic/anaphylactic reactions including
hypersensitivity to the drugs or materials that will be utilized in the study
procedure.
28. Any other medical condition that would not permit elective endoscopy such as poor
general health or history and/or symptoms of severe renal, hepatic, cardiac, and/or
pulmonary disease, and/or physician's assessment that the subject is not an
appropriate candidate.
|
