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

Not Applicable

Completed

• Conditions: Intestinal Diseases

• Registration Number: NCT00398203
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2006-11-08
• Study First Submitted QC: 2006-11-08
• Study First Posted: 2006-11-10
• Study Start: 2008-02
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-11
• Last Update Posted: 2012-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kings College Hospital; 🇬🇧 London, United Kingdom