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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014