Safety and efficacy of using NaviAid™ BGE device for endoscopic diagnosis and treatment

Not Applicable

Completed

• Conditions: Small intestine abnormality; Digestive System; Intestinal disorder

• Registration Number: ISRCTN87379760
• Lead Sponsor: Smart Medical Systems Ltd (Israel)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-14
• Study Completion: 2011-07-31
• Last Update Posted: 1 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male/female aged between 18 and 80 years (inclusive)
2. Subject is scheduled for endoscopic procedure after the case was reviewed by one of the investigators
3. Symptomatic subject defined as having at least one of the following signs or symptoms:
3.1. Abdominal pain
3.2. Cramps
3.3. Bloating
3.4. Diarrhoea
3.5. Nausea
3.6. Vomiting
3.7. Unexplained anaemia
3.8. Gastro-Intestinal (GI) bleeding from an unknown source
3.9. Small bowel abnormality on any imaging study
4. Subject able to comprehend and give informed consent for participation in this study
5. Signed informed consent form

Exclusion Criteria

1. Pregnancy
2. Acute bowel obstruction
3. Concomitant coumadin or warfarin use
4. Severe diverticulitis
5. Recent (within the last three months) coronary ischemia or Coronary Vascular Accident (CVA - stroke)
6. Any chronic unstable disease
7. Bleeding disorders
8. Needing emergency surgery
9. Any patient condition deemed too risky for BGE by the investigator
10. Known cognitive or psychiatric disorder
11. Physician objection
12. Concurrent participation in any other clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified