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

Not Applicable

Completed

Interventions: Device: TransPyloric Shuttle
Device: Sham procedure
Behavioral: Lifestyle Counseling

Brief Summary: 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.

Recruitment & Eligibility

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 participation
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

Arm && Interventions

Group	Intervention	Description
TransPyloric Shuttle (TPS)	TransPyloric Shuttle	TransPyloric Shuttle plus Lifestyle Counseling
Control	Sham procedure	Sham procedure plus Lifestyle Counseling
Control	Lifestyle Counseling	Sham procedure plus Lifestyle Counseling
TransPyloric Shuttle (TPS)	Lifestyle Counseling	TransPyloric Shuttle plus Lifestyle Counseling

Primary Outcome Measures

Name	Time	Method
Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group	12 Months	The mean percent Total Body Weight Loss (% TBL) is the percentage weight change at 12 Months from Baseline
Proportion of TPS-treated Subjects With Weight Loss ≥ 5% TBL	12 months	The proportion of subjects in the TPS group with ≥ 5% TBL is compared to a performance target of 50%

Secondary Outcome Measures

Name	Time	Method

Locations (9): University of California San Diego
🇺🇸
San Diego, California, United States
HonorHealth Bariatric Center
🇺🇸
Scottsdale, Arizona, United States
University of Miami
🇺🇸
Miami, Florida, United States
Stony Brook Medicine
🇺🇸
Stony Brook, New York, United States
MidSouth Bariatrics
🇺🇸
Memphis, Tennessee, United States
Dartmouth-Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Baylor University Medical Center
🇺🇸
Dallas, Texas, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States