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

Intestinal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398203
• Other study ID #: CLI-10111
• 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

• Intestinal Diseases

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