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

Primary Purpose

Intestinal Diseases

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
NaviAid™ BGE Device
Sponsored by
Smart Medical Systems Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal Diseases focused on measuring NaviAid™ BGE Device, Small Intestine, Intestinal Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kings College Hospital

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety of the NaviAid™ BGE Device will be assessed by reporting adverse events, and by comparing to a reference Enteroscopy procedure.

Full Information

First Posted
November 8, 2006
Last Updated
June 11, 2012
Sponsor
Smart Medical Systems Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00398203
Brief Title
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

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smart Medical Systems Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Diseases
Keywords
NaviAid™ BGE Device, Small Intestine, Intestinal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
NaviAid™ BGE Device
Other Intervention Name(s)
NaviAid™ Balloon Guided Endoscopy Device
Intervention Description
NaviAid™ Balloon Guided Endoscopy Device
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingvar Bjarnason, Prof.
Organizational Affiliation
Kings College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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