At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 22 enrolled
Drug / intervention
GI Linerdevice
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.
A Phase II Single-Center, Prospective, Open Label Study of Safety and Efficacy, of the GI Sleeve for Pre-Surgical Weight Loss, in Type II Diabetes Patients (Cohort 06-6B Only)
In Brief
A Phase 2 clinical trial evaluating GI Liner for Type 2 Diabetes and Obesity. Completed, enrolled 22 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes, Obesity
CountriesBrazil
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2008
First PostedNov 2008
Primary CompletionMar 2010
Study CompletionDec 2010
TodayJul 2026
First PostedNov 14, 2008
Enrollment StartOct 1, 2008
Primary CompletionMar 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.6 years ago
Interventions
GI Linerdevice
Medical device placed endoscopically in the duodenum, nutritional counseling