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

June 11, 2012 updated by: Smart Medical Systems Ltd.

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.

Study Overview

Status

Completed

Conditions

Intestinal Diseases

Intervention / Treatment

Device: NaviAid™ BGE 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.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - London, United Kingdom, SE5 9RS
    - Kings College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome 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. Time Frame: Within 6 months of completion of the trial	Within 6 months of completion of the trial

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Within 6 months of completion of the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smart Medical Systems Ltd.

Investigators

Principal Investigator: Ingvar Bjarnason, Prof., Kings College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

November 8, 2006

First Submitted That Met QC Criteria