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Multi-Center Feasibility Study of Trans-oral Endoscopic Restrictive Implant System (TERIS) for Treatment of Obesity

NCT00707720 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-04-10

No results posted yet for this study

Summary

The Barosense Trans-oral Endoscopic Restrictive Implant System (TERIS) is an investigational system being evaluated for safety The system uses endoscopic guidance to trans-orally implant a restrictive reservoir for food entering the stomach in obese and morbidly obese subjects to induce early and prolonged satiety. The Intended Use of the system is for the treatment of obesity.

Conditions

Interventions

DEVICE

TERIS procedure

The implantation of the restrictive implant

Sponsors & Collaborators

  • BaroSense Inc.

    lead INDUSTRY

Principal Investigators

  • Kathy Stecco, MD · Medical Consultant

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-05-31
Completion
2011-12-31

Countries

  • Canada

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 NCT00707720 on ClinicalTrials.gov