The purpose of this study is to evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR) Procedure for the treatment of Type 2 Diabetes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Endoscopic procedure
Hopital Erasme
Brussels, Belgium
UZ Leuven
Leuven, Belgium
Centro Clinico de Obesidad
Santiago, Chile
Università Cattolica del Sacro Cuore, Policlinico A. Gemelli
Rome, Lazio, Italy
mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure
Time frame: 24 weeks post-procedure
Device or procedure related Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
Time frame: 24 weeks post-procedure
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Academic Medical Center
Amsterdam, Netherlands
University College London Hospitals
London, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom