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

July 15, 2019 updated by: BaroNova, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Bariatric Center
    • California
      • San Diego, California, United States, 92103
        • University of California San Diego
    • Florida
      • Miami, Florida, United States, 33166
        • University of Miami
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook Medicine
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • MidSouth Bariatrics
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TransPyloric Shuttle (TPS)
TransPyloric Shuttle plus Lifestyle Counseling
Device: TransPyloric Shuttle
Other Names:
  • 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
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.
Device: Sham procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 Months
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%
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BaroNova, Inc.

Investigators

  • Principal Investigator: Richard I Rothstein, MD, Dartmouth Geisel School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

August 6, 2015

First Posted (Estimate)

August 10, 2015

Study Record Updates

Last Update Posted (Actual)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DTC006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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