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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518685
Recruitment Status : Completed
First Posted : August 10, 2015
Results First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
BaroNova, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Device: TransPyloric Shuttle Device: Sham procedure Behavioral: Lifestyle Counseling Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TransPyloric Shuttle (TPS)
TransPyloric Shuttle plus Lifestyle Counseling
 Device: TransPyloric Shuttle
Other Name: TPS

Behavioral: Lifestyle Counseling
The goal of lifestyle modification counseling is to promote adherence to a reduced calorie diet, increased physical activity and to recommend behavioral modification strategies.
Sham Comparator: Control
Sham procedure plus Lifestyle Counseling
 Device: Sham procedure
Behavioral: Lifestyle Counseling
The goal of lifestyle modification counseling is to promote adherence to a reduced calorie diet, increased physical activity and to recommend behavioral modification strategies.


Outcome Measures
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Primary Outcome Measures :
  1. Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group [ Time Frame: 12 Months ]
    The mean percent Total Body Weight Loss (% TBL) is the percentage weight change at 12 Months from Baseline

  2. Proportion of TPS-treated Subjects With Weight Loss ≥ 5% TBL [ Time Frame: 12 months ]
    The proportion of subjects in the TPS group with ≥ 5% TBL is compared to a performance target of 50%


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518685


Locations
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United States, Arizona
HonorHealth Bariatric Center
Scottsdale, Arizona, United States, 85258
United States, California
University of California San Diego
San Diego, California, United States, 92103
United States, Florida
University of Miami
Miami, Florida, United States, 33166
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Stony Brook Medicine
Stony Brook, New York, United States, 11794
United States, Tennessee
MidSouth Bariatrics
Memphis, Tennessee, United States, 38120
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
BaroNova, Inc.
Investigators
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Principal Investigator: Richard I Rothstein, MD Dartmouth Geisel School of Medicine
  Study Documents (Full-Text)

Documents provided by BaroNova, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] November 15, 2016

More Information
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Responsible Party: BaroNova, Inc.
ClinicalTrials.gov Identifier: NCT02518685    
Other Study ID Numbers: DTC006
First Posted: August 10, 2015    Key Record Dates
Results First Posted: July 17, 2019
Last Update Posted: July 17, 2019
Last Verified: April 2019
Keywords provided by BaroNova, Inc.:
Obesity
Weight loss
Device
Non-surgical
 Endoscopic
TransPyloric Shuttle
TPS
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight