Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment
NCT ID: NCT00398203
Last Updated: 2012-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2008-02-29
2011-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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NaviAid™ BGE Device
NaviAid™ Balloon Guided Endoscopy Device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Smart Medical Systems Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ingvar Bjarnason, Prof.
Role: PRINCIPAL_INVESTIGATOR
Kings College Hospital
Locations
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Kings College Hospital
London, , United Kingdom
Countries
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Other Identifiers
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CLI-10111
Identifier Type: -
Identifier Source: org_study_id
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