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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Smart Medical Systems Ltd.
ClinicalTrials.gov Identifier:
NCT00398203
First received: November 8, 2006
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Intestinal Diseases
 Device: NaviAid™ BGE Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Smart Medical Systems Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: February 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: NaviAid™ BGE Device
    NaviAid™ Balloon Guided Endoscopy Device
    Other Name: NaviAid™ Balloon Guided Endoscopy Device
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Smart Medical Systems Ltd.
ClinicalTrials.gov Identifier: NCT00398203     History of Changes
Other Study ID Numbers: CLI-10111
Study First Received: November 8, 2006
Last Updated: June 11, 2012
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on May 19, 2013