Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment
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.
Inclusion Criteria:
Male/Female aged between 18-80 years (inclusive).
Subject is scheduled for endoscopic procedure after the case was reviewed by one of the investigators.
Symptomatic subject defined as having at least one of the following signs or symptoms:
Subject able to comprehend and give informed consent for participation in this study
Signed Informed Consent Form
Exclusion Criteria: