Intestinal Diseases Clinical Trial
Official title:
Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment
To assess the efficacy of the NaviAid™ BGE Device, while used in conjunction with a standard endoscope for the diagnosis and treatment of the small intestine.
Smart Medical Systems has developed the NaviAid™ Balloon Guided Endoscopy (BGE) Device, an
innovative medical device for the GI tract diagnosis and treatment. The Balloon Guided
Endoscopy (BGE) is a procedure intended for the examination of the small intestine, which
utilizes the NaviAid™ BGE Device in conjunction with a standard endoscope.
The objectives of this prospective controlled study are to evaluate the safety and efficacy
of using the NaviAid™ BGE device in the examination of the small intestine in conjunction
with a standard endoscope.
Efficacy will be assessed by comparing NaviAid™ BGE Device performances to a reference
Enteroscopy procedure.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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