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

Smart Medical Systems

Status: Completed

Conditions: Intestinal Diseases

Treatments: Device: NaviAid™ BGE Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00398203

CLI-10111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)