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Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese

NCT01728116 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2017-02-01

Study results available
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Summary

To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes

Conditions

Interventions

DEVICE

EndoBarrier

Endoscopically-delivered and removable device comprised of an anchor that is placed in the duodenal bulb and a 60 cm long impermeable liner that passes distal from the anchor point

PROCEDURE

Sham Procedure

Endoscopic evaluation but no device placement

Sponsors & Collaborators

  • Morphic Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Lee M Kaplan, MD, PhD · Massachusetts General Hospital

  • Keith Gersin, MD · Carolinas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2016-02-29
Completion
2016-02-29

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 NCT01728116 on ClinicalTrials.gov