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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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TransPyloric Shuttle (TPS)

TransPyloric Shuttle plus Lifestyle Counseling

Group Type EXPERIMENTAL

TransPyloric Shuttle

Intervention Type DEVICE

Lifestyle Counseling

Intervention Type BEHAVIORAL

The goal of lifestyle modification counseling is to promote adherence to a reduced calorie diet, increased physical activity and to recommend behavioral modification strategies.

Control

Sham procedure plus Lifestyle Counseling

Group Type SHAM_COMPARATOR

Sham procedure

Intervention Type DEVICE

Lifestyle Counseling

Intervention Type BEHAVIORAL

The goal of lifestyle modification counseling is to promote adherence to a reduced calorie diet, increased physical activity and to recommend behavioral modification strategies.

Interventions

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TransPyloric Shuttle

Intervention Type DEVICE

Sham procedure

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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TPS

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No