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

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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.

Tracking Information
First Submitted Date  ICMJE August 6, 2015
First Posted Date  ICMJE August 10, 2015
Results First Submitted Date  ICMJE April 20, 2019
Results First Posted Date  ICMJE July 17, 2019
Last Update Posted Date July 17, 2019
Study Start Date  ICMJE September 2015
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • 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
  • 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%
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT02518685 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ENDObesity® II Study: TransPyloric Shuttle® System for Weight Loss
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Device: TransPyloric Shuttle
    Other Name: TPS
  • 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.
Study Arms  ICMJE
  • Experimental: TransPyloric Shuttle (TPS)
    TransPyloric Shuttle plus Lifestyle Counseling
    Interventions:
    • Device: TransPyloric Shuttle
    • Behavioral: Lifestyle Counseling
  • Sham Comparator: Control
    Sham procedure plus Lifestyle Counseling
    Interventions:
    • Device: Sham procedure
    • Behavioral: Lifestyle Counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2019)
302
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02518685
Other Study ID Numbers  ICMJE DTC006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BaroNova, Inc.
Study Sponsor  ICMJE BaroNova, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard I Rothstein, MD Dartmouth Geisel School of Medicine
PRS Account BaroNova, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP