Status:
COMPLETED
Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment
Lead Sponsor:
Smart Medical Systems Ltd.
Conditions:
Intestinal Diseases
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00398203
Start Date
February 1 2008
End Date
June 1 2011
Last Update
June 12 2012
Active Locations (1)
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1
Kings College Hospital
London, United Kingdom, SE5 9RS