CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
EndoBarrier Gastrointestinal Liner +1 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/NCT02709577
NCT02709577Phase 2Completed
CompareCT.gov

A Pilot Feasibility Sham Controlled Study of the GI Sleeve for the Treatment of Type 2 Diabetes

Morphic Medical Inc.·interventional·Posted Mar 16, 2016·Updated Dec 28, 2016

In Brief

A Phase 2 clinical trial evaluating EndoBarrier Gastrointestinal Liner and Sham: endoscopy and standard of care for Type 2 Diabetes. Completed, enrolled 36 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
Countries--
CollaboratorsHospital Dipreca

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 16, 2016
Enrollment StartJan 1, 2007
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 10.3 years ago

Interventions

EndoBarrier Gastrointestinal Linerdevice

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.

Sham: endoscopy and standard of careother

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