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ISRCTN
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ISRCTN87379760
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ClinicalTrials.gov identifier
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NCT00398203
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Public title
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Safety and efficacy of using NaviAid™ BGE device for endoscopic diagnosis and treatment
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Scientific title
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Acronym
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N/A
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Serial number at source
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Protocol No. 1
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Study hypothesis
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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.
As of 17/05/2011 the anticipated end date for this trial has been updated from 01/09/2007 to 31/07/2011.
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Lay summary
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Ethics approval
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Approval is expected by the end of December 2006.
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Study design
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Open label, randomised-controlled, double arm, single centre study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Small intestine abnormality
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2007
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Anticipated end date
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31/07/2011
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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60
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Interventions
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The intervations in this study are enteroscopy and BGE procedure.
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Primary outcome measure(s)
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Depth of small intestine visualisation
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Secondary outcome measure(s)
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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
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Sources of funding
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Smart Medical Systems Ltd (Israel)
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Trial website
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Publications
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Contact name
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Prof
Ingvar
Bjarnason
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Address
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King's College Hospital
Denmark Hill
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City/town
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London
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Zip/Postcode
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SE5 9RS
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Country
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United Kingdom
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Sponsor
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Smart Medical Systems Ltd (Israel)
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Address
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10 Hayetsira Street
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City/town
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Ra'anana
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Zip/Postcode
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43663
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Country
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Israel
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Date applied
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08/11/2006
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Last edited
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17/05/2011
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Date ISRCTN assigned
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14/11/2006
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