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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Device: TransPyloric Shuttle
* Device: Sham procedure
* Behavioral: Lifestyle Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TransPyloric Shuttle (TPS)<br>TransPyloric Shuttle plus Lifestyle Counseling | Device: TransPyloric Shuttle<br> <br> * Other names: TPS;Behavioral: Lifestyle Counseling<br>* The goal of lifestyle modification counseling is to promote adherence to a reduced calorie diet, increased physical activity and to recommend behavioral modification strategies.<br>|
| Sham Comparator: Control<br>Sham procedure plus Lifestyle Counseling | Device: Sham procedure<br> <br> Behavioral: Lifestyle Counseling<br>* The goal of lifestyle modification counseling is to promote adherence to a reduced calorie diet, increased physical activity and to recommend behavioral modification strategies.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Device, Weight loss, Non-surgical, Endoscopic, TransPyloric Shuttle, TPS