N/A
N=302
ENDObesity® II Study: TransPyloric Shuttle® System for Weight Loss
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02518685 ↗Enrolled (actual)
302
Serious AEs
3.6%
Results posted
Jul 2019
Primary outcome: Primary: Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group — 9.5; 2.8 % Total Body Weight Loss — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TransPyloric Shuttle (Device); Sham procedure (Device); Lifestyle Counseling (Behavioral)
- Age
- Adult · 22+ yrs
- Sex
- All
- Sponsor
- BaroNova, Inc.
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group |
9.5; 2.8 | <0.0001 sig |
| PRIMARY Proportion of TPS-treated Subjects With Weight Loss ≥ 5% TBL |
112 | <0.0001 sig |
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.
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
- 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
Data sourced from ClinicalTrials.gov (NCT02518685). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.