Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment

Conditions
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Intestinal Diseases

Intervention / Treatment
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* Device: NaviAid™ BGE Device


Participation Criteria
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Eligibility Criteria
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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: Abdominal pain Cramps Bloating Diarrhea Nausea Vomiting Unexplained Anemia GI bleeding from an unknown source Small bowel abnormality on any imaging study Subject able to comprehend and give informed consent for participation in this study Signed Informed Consent Form Exclusion Criteria: Pregnancy Acute bowel obstruction Concomitant Coumadin or warfarin use Severe diverticulitis Recent (within the last 3 months) coronary ischemia or CVA (stroke) Any chronic unstable disease Bleeding disorders Needing emergency surgery Any patient condition deemed too risky for SBE by the investigator Known cognitive or psychiatric disorder Physician objection Concurrent participation in any other clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NaviAid™ BGE Device|NaviAid™ Balloon Guided Endoscopy Device|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy will be assessed by comparing NaviAid™ BGE Device performances to a reference Enteroscopy procedure in terms of depth of small intestine advancement and visualization. |  | Within 6 months of completion of the trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the NaviAid™ BGE Device will be assessed by reporting adverse events, and by comparing to a reference Enteroscopy procedure. |  | Within 6 months of completion of the trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NaviAid™ BGE Device, Small Intestine, Intestinal Diseases