Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT02293720
Brief 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.
Detailed Description:
This is an open-label extension study for subjects who participated in the control arm of study #09-1 (A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Oral Anti-Diabetes Agents) who are not treatment failures and completed 12 months of the study.
Study:
NCT02293720
Study Brief:
Protocol Section:
NCT02293720