Clinical trial NCT00398203: Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment
Official title: Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Diseases
Keywords: NaviAid™ BGE Device
Small Intestine
Intestinal Diseases
Lead sponsor: Smart Medical Systems Ltd.
Sponsor class: INDUSTRY
First posted: 2006-11-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: Within 6 months of completion of the trial
Secondary outcomes:
measure: Safety of the NaviAid™ BGE Device will be assessed by reporting adverse events, and by comparing to a reference Enteroscopy procedure.
timeFrame: Within 6 months of completion of the trial
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: Kings College Hospital
name: Ingvar Bjarnason, Prof.
role: PRINCIPAL_INVESTIGATOR
References: