Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-30 @ 11:02 PM
Study NCT ID:
NCT00398203
Status:
COMPLETED
Last Update Posted:
2012-06-12
First Post:
2006-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007410', 'term': 'Intestinal Diseases'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-11', 'studyFirstSubmitDate': '2006-11-08', 'studyFirstSubmitQcDate': '2006-11-08', 'lastUpdatePostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'Within 6 months of completion of the trial'}], 'secondaryOutcomes': [{'measure': 'Safety of the NaviAid™ BGE Device will be assessed by reporting adverse events, and by comparing to a reference Enteroscopy procedure.', 'timeFrame': 'Within 6 months of completion of the trial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NaviAid™ BGE Device', 'Small Intestine', 'Intestinal Diseases'], 'conditions': ['Intestinal Diseases']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nEfficacy will be assessed by comparing NaviAid™ BGE Device performances to a reference Enteroscopy procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/Female aged between 18-80 years (inclusive).\n* Subject is scheduled for endoscopic procedure after the case was reviewed by one of the investigators.\n* Symptomatic subject defined as having at least one of the following signs or symptoms:\n\n * Abdominal pain\n * Cramps\n * Bloating\n * Diarrhea\n * Nausea\n * Vomiting\n * Unexplained Anemia\n * GI bleeding from an unknown source\n * Small bowel abnormality on any imaging study\n* Subject able to comprehend and give informed consent for participation in this study\n* Signed Informed Consent Form\n\nExclusion Criteria:\n\n* Pregnancy\n* Acute bowel obstruction\n* Concomitant Coumadin or warfarin use\n* Severe diverticulitis\n* Recent (within the last 3 months) coronary ischemia or CVA (stroke)\n* Any chronic unstable disease\n* Bleeding disorders\n* Needing emergency surgery\n* Any patient condition deemed too risky for SBE by the investigator\n* Known cognitive or psychiatric disorder\n* Physician objection\n* Concurrent participation in any other clinical trial'}, 'identificationModule': {'nctId': 'NCT00398203', 'briefTitle': 'Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smart Medical Systems Ltd.'}, 'officialTitle': 'Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment', 'orgStudyIdInfo': {'id': 'CLI-10111'}}, 'armsInterventionsModule': {'interventions': [{'name': 'NaviAid™ BGE Device', 'type': 'DEVICE', 'otherNames': ['NaviAid™ Balloon Guided Endoscopy Device'], 'description': 'NaviAid™ Balloon Guided Endoscopy Device'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Kings College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Ingvar Bjarnason, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kings College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smart Medical Systems Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}