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

NCT02518685 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2019-07-17

Study results available
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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.

Conditions

Interventions

DEVICE

TransPyloric Shuttle

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.

Sponsors & Collaborators

  • BaroNova, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard I Rothstein, MD · Dartmouth Geisel School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-12-31
Completion
2018-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02518685 on ClinicalTrials.gov