Clinical trial NCT02518685: ENDObesity® II Study: TransPyloric Shuttle® System for Weight Loss
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Weight loss
Device
Non-surgical
Endoscopic
TransPyloric Shuttle
TPS
Lead sponsor: BaroNova, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-10
Enrollment: 302
Sex: ALL
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group
timeFrame: 12 Months
measure: Proportion of TPS-treated Subjects With Weight Loss ≥ 5% TBL
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Bariatric Center
state: Arizona
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Memphis
country: United States
facility: MidSouth Bariatrics
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Dartmouth Geisel School of Medicine
name: Richard I Rothstein, MD
role: PRINCIPAL_INVESTIGATOR
References: