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A Study of the GI Sleeve for the Treatment of Type 2 Diabetes

NCT02709577 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-12-28

Study results available
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Summary

The purpose of the study was to evaluate the safety and efficacy of the EndoBarrier Gastrointestinal Liner compared to sham control in subjects with Type 2 diabetes.

Conditions

Interventions

DEVICE

EndoBarrier Gastrointestinal Liner

The EndoBarrier is a single use, implant consisting of a tube of composite material which is placed in the proximal section of the duodenum. The implant is fixed in place with the aid of a metal anchor. The device is delivered via an endoscope. The implant facilitates the passage of food from the stomach through the tube to the proximal section of the jejunum.

OTHER

Sham: endoscopy and standard of care

Sham subjects had an endoscopic procedure and then received standard of care treatment of their diabetes

Sponsors & Collaborators

  • Hospital Dipreca

    collaborator OTHER

  • Morphic Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Leonardo Rodriguez Grunert, MD · Hospital Dipreca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-01-31
Completion
2009-01-31

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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 NCT02709577 on ClinicalTrials.gov