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

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ClinicalTrials.gov Identifier: NCT00398203
Recruitment Status : Completed
First Posted : November 10, 2006
Last Update Posted : June 12, 2012
Sponsor:
Information provided by (Responsible Party):
Smart Medical Systems Ltd.

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.

Condition or disease Intervention/treatment Phase
Intestinal Diseases Device: NaviAid™ BGE Device Not Applicable

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 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment
Study Start Date : February 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources


Intervention Details:
    Device: NaviAid™ BGE Device
    NaviAid™ Balloon Guided Endoscopy Device
    Other Name: NaviAid™ Balloon Guided Endoscopy Device


Primary Outcome Measures :
  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. [ Time Frame: Within 6 months of completion of the trial ]

Secondary Outcome Measures :
  1. Safety of the NaviAid™ BGE Device will be assessed by reporting adverse events, and by comparing to a reference Enteroscopy procedure. [ Time Frame: Within 6 months of completion of the trial ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398203


Locations
United Kingdom
Kings College Hospital
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Smart Medical Systems Ltd.
Investigators
Principal Investigator: Ingvar Bjarnason, Prof. Kings College Hospital

Responsible Party: Smart Medical Systems Ltd.
ClinicalTrials.gov Identifier: NCT00398203     History of Changes
Other Study ID Numbers: CLI-10111
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: June 12, 2012
Last Verified: June 2012

Keywords provided by Smart Medical Systems Ltd.:
NaviAid™ BGE Device
Small Intestine
Intestinal Diseases

Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases