ENDObesity® II Study: TransPyloric Shuttle® System for Weight Loss
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
1 other identifier
interventional
302
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Sep 2015
Typical duration for not_applicable obesity
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2015
CompletedFirst Posted
Study publicly available on registry
August 10, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedResults Posted
Study results publicly available
July 17, 2019
CompletedJuly 17, 2019
April 1, 2019
2.3 years
August 6, 2015
April 20, 2019
July 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
TransPyloric Shuttle (TPS)
EXPERIMENTALTransPyloric Shuttle plus Lifestyle Counseling
Control
SHAM COMPARATORSham procedure plus Lifestyle Counseling
Interventions
The goal of lifestyle modification counseling is to promote adherence to a reduced calorie diet, increased physical activity and to recommend behavioral modification strategies.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BaroNova, Inc.lead
Study Sites (9)
HonorHealth Bariatric Center
Scottsdale, Arizona, 85258, United States
University of California San Diego
San Diego, California, 92103, United States
University of Miami
Miami, Florida, 33166, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Stony Brook Medicine
Stony Brook, New York, 11794, United States
MidSouth Bariatrics
Memphis, Tennessee, 38120, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lian Cunningham, MD, PhD
- Organization
- BAROnova, Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Richard I Rothstein, MD
Dartmouth Geisel School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2015
First Posted
August 10, 2015
Study Start
September 1, 2015
Primary Completion
December 1, 2017
Study Completion
March 1, 2018
Last Updated
July 17, 2019
Results First Posted
July 17, 2019
Record last verified: 2019-04