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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TransPyloric Shuttle
Sham procedure
Lifestyle Counseling
Sponsored by
BaroNova, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight loss, Device, Non-surgical, Endoscopic, TransPyloric Shuttle, TPS

Eligibility Criteria

22 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HonorHealth Bariatric Center
  • University of California San Diego
  • University of Miami
  • Washington University School of Medicine
  • Dartmouth-Hitchcock Medical Center
  • Stony Brook Medicine
  • MidSouth Bariatrics
  • Vanderbilt University Medical Center
  • Baylor University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

TransPyloric Shuttle (TPS)

Control

Arm Description

TransPyloric Shuttle plus Lifestyle Counseling

Sham procedure plus Lifestyle Counseling

Outcomes

Primary Outcome Measures

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
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%

Secondary Outcome Measures

Full Information

First Posted
August 6, 2015
Last Updated
July 15, 2019
Sponsor
BaroNova, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02518685
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BaroNova, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Weight loss, Device, Non-surgical, Endoscopic, TransPyloric Shuttle, TPS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TransPyloric Shuttle (TPS)
Arm Type
Experimental
Arm Description
TransPyloric Shuttle plus Lifestyle Counseling
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Sham procedure plus Lifestyle Counseling
Intervention Type
Device
Intervention Name(s)
TransPyloric Shuttle
Other Intervention Name(s)
TPS
Intervention Type
Device
Intervention Name(s)
Sham procedure
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Counseling
Intervention Description
The goal of lifestyle modification counseling is to promote adherence to a reduced calorie diet, increased physical activity and to recommend behavioral modification strategies.
Primary Outcome Measure Information:
Title
Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group
Description
The mean percent Total Body Weight Loss (% TBL) is the percentage weight change at 12 Months from Baseline
Time Frame
12 Months
Title
Proportion of TPS-treated Subjects With Weight Loss ≥ 5% TBL
Description
The proportion of subjects in the TPS group with ≥ 5% TBL is compared to a performance target of 50%
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard I Rothstein, MD
Organizational Affiliation
Dartmouth Geisel School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
HonorHealth Bariatric Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Stony Brook Medicine
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
MidSouth Bariatrics
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

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

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