CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 302 enrolled
Drug / intervention
TransPyloric Shuttle +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02518685
NCT02518685N/ACompleted

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

BaroNova, Inc.·interventional·Posted Aug 10, 2015·Updated Jul 17, 2019

In Brief

A clinical study evaluating TransPyloric Shuttle, Sham procedure, and 1 other intervention for Obesity. Completed, enrolled 302 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 10, 2015
Enrollment StartSep 1, 2015
Primary CompletionDec 1, 2017
Study CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.9 years ago

Interventions

TransPyloric Shuttledevice

Sham proceduredevice

Lifestyle Counselingbehavioral

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