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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02518685
First Posted: August 10, 2015
Last Update Posted: April 12, 2017
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.
Information provided by (Responsible Party):
BaroNova, Inc.
  Purpose
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 Intervention
Obesity Device: TransPyloric Shuttle Behavioral: lifestyle counseling Device: Sham procedure

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by BaroNova, Inc.:

Primary Outcome Measures:
  • Mean percent Total Body Weight Loss (% TBL) between Treatment and Control group [ Time Frame: 12 months ]
  • Proportion of subjects with greater than or equal to 5% TBL in Treatment group [ Time Frame: 12 months ]

Estimated Enrollment: 270
Study Start Date: September 2015
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TransPyloric Shuttle (TPS)
TransPyloric Shuttle plus lifestyle counseling
Device: TransPyloric Shuttle
Other Name: TPS
Behavioral: lifestyle counseling
Sham Comparator: Control
Sham procedure plus lifestyle counseling.
Behavioral: lifestyle counseling Device: Sham procedure

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
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
St. 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.
  More Information

Additional Information:
Responsible Party: BaroNova, Inc.
ClinicalTrials.gov Identifier: NCT02518685     History of Changes
Other Study ID Numbers: DTC006
First Submitted: August 6, 2015
First Posted: August 10, 2015
Last Update Posted: April 12, 2017
Last Verified: April 2017

Keywords provided by BaroNova, Inc.:
Obesity
Weight loss
Device
Non-surgical
Endoscopic
TransPyloric Shuttle
TPS

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms