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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00398203

Enrollment

Registered

2006-11-10

Start date

2008-02-29

Completion date

2011-06-30

Last updated

2012-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Diseases

Keywords

NaviAid™ BGE Device, Small Intestine, Intestinal Diseases

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.

Interventions

DEVICENaviAid™ BGE Device

NaviAid™ Balloon Guided Endoscopy Device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026