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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00398203
Other study ID # CLI-10111
Secondary ID
Status Completed
Phase N/A
First received November 8, 2006
Last updated June 11, 2012
Start date February 2008
Est. completion date June 2011

Study information

Verified date June 2012
Source Smart Medical Systems Ltd.
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
NaviAid™ BGE Device
NaviAid™ Balloon Guided Endoscopy Device

Locations

Country Name City State
United Kingdom Kings College Hospital London

Sponsors (1)

Lead Sponsor Collaborator
Smart Medical Systems Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 Yes
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