Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00398203
Protocol/serial number
Protocol No. 1
Study information
Scientific title
Safety and efficacy of using NaviAid™ BGE device for endoscopic diagnosis and treatment
Acronym
Study hypothesis
Balloon Guided Endoscopy (BGE) is a procedure intended for the examination of the small intestine, which utilises the NaviAid™ BGE device in conjunction with a standard endoscope.
Hypothesis:
To assess the efficacy of the Naviaid™ Balloon Guided Endoscope (BGE) device, while used in conjunction with a standard endoscope for the diagnosis and treatment of the small intestine.
Ethics approval
Not provided at time of registration
Study design
Open label randomised-controlled double arm single centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Small intestine abnormality
Intervention
The intervations in this study are enteroscopy and BGE procedure.
Intervention type
Device
Phase
Not Specified
Drug names
Primary outcome measures
Depth of small intestine visualisation
Secondary outcome measures
The safety endpoint is incidence of treatment related major complications. Major complications are:
1. Blood transfusion
2. Adverse event requiring treatment associated with elongation of hospital stay for more than 24 hours beyond the standard at the specific site
3. Complications associated with permanent sequelae
4. Death
Overall trial start date
01/01/2007
Overall trial end date
31/07/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
01/01/2007
Recruitment end date
31/07/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College Hospital
London
SE5 9RS
United Kingdom
Funders
Funder type
Industry
Funder name
Smart Medical Systems Ltd (Israel)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary