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An Open-Label Extension to Protocol 09-1, Efficacy and Safety Study of the EndoBarrier® Gastrointestinal Liner System

NCT02293720 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-09-14

No results posted yet for this study

Summary

A multi-center, single-arm, open-label study to evaluate the safety and effectiveness of the EndoBarrier Gastrointestinal Liner System liner on glycemic control in control subjects from study #09-1 who are not treatment failures and have completed 12 months of the study.

Conditions

Interventions

DEVICE

EndoBarrier

The EndoBarrier is indicated as an adjunct to diet and exercise to achieve weight loss and improve glycemic control in obese adults with type 2 diabetes whose anti-diabetes medications have not achieved adequate glycemic control.

Sponsors & Collaborators

  • Morphic Medical Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-07-31
Completion
2016-07-31

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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 NCT02293720 on ClinicalTrials.gov