Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2006
CompletedFirst Posted
Study publicly available on registry
November 10, 2006
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 12, 2012
June 1, 2012
3.3 years
November 8, 2006
June 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Interventions
NaviAid™ Balloon Guided Endoscopy Device
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kings College Hospital
London, SE5 9RS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ingvar Bjarnason, Prof.
Kings College Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2006
First Posted
November 10, 2006
Study Start
February 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 12, 2012
Record last verified: 2012-06