Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This study has been expanded to a four center, open-label, 2-group randomized pilot study
evaluating a treatment for obesity.
Phase
N/A
Funding Agency/Sponsor
Industry
Disease
Laparoendscopic and Bariatric Surgery
Enrollment 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 22-60 years.
4. 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.
5. Have a Body Mass Index (BMI) of ≥ 35 and < 40 with one or more obesity related
co-morbid conditions (defined by 1991 NIH Guidelines (Appropriateness Criteria for
Bariatric Surgery: Beyond the NIH Guidelines)).
1. Pre-diabetes - Fasting plasma glucose test >100 mg/dl but ≤125 or oral glucose
tolerance test ≥140 mg/dl but <200.
2. Diabetes - Individuals taking insulin and/or oral hypoglycemic medications or
have a fasting glucose >126 mg/dl.
3. Hypertension - SBP>140 or DBP>90 or the use of an antihypertensive medication.
4. Dyslipidemia - Triglycerides > 250 mg/dl or cholesterol > 220 mg/dl or HDL < 35
mg/dl or LDL > 200 or use of lipid lowering medications.
5. Sleep Apnea - A formal sleep study test consistent with this diagnosis; Epworth
sleepiness scale ≥ 6; Polysomnography with respiratory disturbance index ≥ 10
hypopneic and/or apneic episodes per hour of sleep.
6. Venous Stasis Disease - Presence or history of pretibial venous stasis ulcers.
7. Chronic Joint Disease - Deterioration of joint cartilage and the formation of new
bone (bone spurs) at the margins of the joints.
6. 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).
7. Agrees not to undergo any additional weight loss interventional procedures or
liposuction for 12 months following study enrollment.
8. Have not taken any prescription or over the counter weight loss medications or those
that can suppress appetite/induce weight loss for at least 6 months and agrees not to
utilize for 12 months following study enrollment (including all stimulant medication).
9. Subjects must be willing to possibly forego any future weight loss procedures (i.e.
Vertical Sleeve Gastrectomy) given the unknown long-term effects.
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. Pregnancy or plans of pregnancy 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. Type II Diabetes Mellitus (as defined by HgbA1c >6.5%) for greater than 11 years at
the time of enrollment.
16. If smoker, plans to quit smoking in the year after enrollment.
17. Portal hypertension and/or varices.
18. Patient has a history of drug or alcohol abuse or positive at screening for drugs of
abuse.
19. Present or history of psychosis, bipolar disease, or obsessive-compulsive disorder
after pre-enrollment history and medical /psychological assessment.
20. Beck Depression Inventory (Short) Score ≥ 12 and/or uncontrolled depression after
pre-enrollment psychological and medical assessment.
21. Patient score >2 in any of the 9 identified symptoms on the Gastroparesis Cardinal
Symptom Index (GCSI)
22. Patient with a 13C-Spirulina Gastric Emptying Breath Test (GEBT) result that is less
than a kPCD/min of 34.4 at 120 minutes or 43 at 180 minutes
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. Participating in another clinical study.
26. Subjects with a personal history of allergic/anaphylactic reactions including
hypersensitivity to the drugs or materials that will be utilized in the study
procedure.
27. Physician's assessment that the subject is not an appropriate candidate. If
significant findings for depression and/or suicidal ideation are identified, the
psychologist(s) assigned to the study will be contacted and arrangement will be made
for immediate intervention according to the Institution's standard procedure.