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CompletedNCT00398203Updated Jun 12, 2012

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

An interventional study of NaviAid™ BGE Device in Intestinal Diseases, sponsored by Smart Medical Systems Ltd.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-06-12.

Sponsored by Smart Medical Systems Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Intestinal Diseases

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Keywords

  • NaviAid™ BGE Device
  • Small Intestine
  • Intestinal Diseases
03

In context

Intestinal Diseases

963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 552 interventional studies indexed under Intestinal Diseases.

Browse Intestinal Diseases studies →

Lead sponsor

Smart Medical Systems Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Interventions

  • DeviceNaviAid™ BGE Device

    NaviAid™ Balloon Guided Endoscopy Device

    Also known as: NaviAid™ Balloon Guided Endoscopy Device

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

07

Study locations

1 site
  • Kings College Hospital
    London, SE5 9RS, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00398203
Lead sponsor
Smart Medical Systems Ltd.
Responsible party
Sponsor
First posted
Nov 10, 2006
Start date
Feb 2008
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Jun 12, 2012

Study contacts

Ingvar Bjarnason, Prof.
principal investigator · Kings College Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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Smart Medical Systems Ltd.

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