N/A Completed N=302 Randomized Double-blind Treatment

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

Obesity

Source: ClinicalTrials.gov NCT02518685 ↗

Enrolled (actual)

302

Serious AEs

3.6%

Results posted

Jul 2019

Primary outcomePrimary: 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

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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.