A Pilot Trial of the EndoBarrier™ Flow Restrictor for Glycemic Improvement in Type 2 Diabetics
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|ClinicalTrials.gov Identifier: NCT00973960|
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : August 8, 2011
The main objective of the study is to demonstrate the safety and efficacy of the EndoBarrier Flow Restrictor in the glycemic control of diabetes in subjects with Type 2 diabetes.
The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c.
|Condition or disease|
|Type 2 Diabetes|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||A Pilot Trial of the EndoBarrier™ Flow Restrictor for Glycemic Improvement in Type 2 Diabetics|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||December 2010|
- The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c. [ Time Frame: 24 weeks ]
- The safety endpoint will be the incidence and severity of anticipated and unanticipated adverse events (device and non-device related). [ Time Frame: 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973960
|Hospital Universidad Catolica|
|Principal Investigator:||Alex Escalona, MD||Hospital Universidad Catolica|