ENDObesity® II Study: TransPyloric Shuttle® System for Weight Loss

Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Age Range:22 - 60
Start Date:September 2015
End Date:March 2018

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Endoscopic Treatment for Weight Reduction in Patients With Obesity Using the TransPyloric Shuttle® System: A Multicenter, Prospective, Randomized, Double-Blind, Sham-Controlled, Parallel-Design Study

The purpose of this clinical research trial is to study safety and effectiveness of the
TransPyloric Shuttle System (TPSS) for weight reduction in patients who are considered
medically obese.

Inclusion Criteria:

- Male and female subjects between the ages of 22 to 60

- A BMI between 30.0 to 40.0 kg/m2, inclusive. Subjects with a BMI of 30.0 kg/m2 to 34.9
kg/m2 are required to have one or more obesity-related comorbidities

- History of obesity for at least 2 years, with history of failure of medically or
commercially supervised weight loss program

- < 5% change in body weight for at least 3 months

- Negative pregnancy test, agree to be on birth control for the duration of

- Informed consent

- Willing and able to comply with study procedures

Exclusion Criteria:

- Pregnancy or nursing

- Hormonal or genetic cause for obesity

- Prior history of any GI surgery or endoscopic intervention

- Chronic use of medications likely to contribute to weight gain or prevent weight loss

- Gastric or duodenal ulcers

- Positive for H. pylori

- History of severe dyspepsia

- GI tract motility disorders

- History of inflammatory disease of GI tract, coeliac disease, pancreatitis, portal
hypertension, cirrhosis, and/or varices

- Diabetes treated with insulin

- HbA1c >7.5%

- Uncontrolled thyroid and adrenal gland disease or uncontrolled hypertension

- History of certain cardiac events

- Localized or systemic infection

- Anemia

- History of asthma likely to require systemic steroid therapy

- Autoimmune connective tissue disorders or immunocompromised

- History of malignancy except non-melanoma skin cancer

- Continuous use of ulcerogenic medication

- On anticoagulation or antiplatelet therapy

- Use of weight-loss medication

- In other weight-loss program

- Unable to take proton pump inhibitor

- Abnormal laboratory values or EKG

- Inability to walk at least 0.8 kilometers per day

- Planned surgical procedure that can impact the conduct of the study

- Known allergy to any component materials in the TPSS

- Smoker or user of nicotine product

- Substance abuse

- Severe, uncontrolled psychiatric illness

- Recent inpatient psychiatric treatment

- Moderate depression

- Bulimia nervosa or binge eating disorder

- Participation in another clinical study

- Employee or family member of Sponsor or study staff

- Have any endoscopic exclusion criteria
We found this trial at
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
Lebanon, NH
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3500 Gaston Avenue
Dallas, Texas 75246
Phone: 214-820-9907
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
Dallas, TX
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
Miami, FL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
Nashville, TN
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Memphis, Tennessee 38120
Phone: 901-869-2000
Memphis, TN
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Saint Louis, MO
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San Diego, California 92093
Phone: 619-471-0447
San Diego, CA
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Scottsdale, Arizona 85258
Scottsdale, AZ
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Stony Brook, New York 11794
Stony Brook, NY
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