Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-26 @ 5:46 PM
Study NCT ID:
NCT02651857
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
2016-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study of Upper and Lower Endoscopic Fuse System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2017-04-27'}, 'lastUpdateSubmitDate': '2017-04-27', 'studyFirstSubmitDate': '2016-01-05', 'studyFirstSubmitQcDate': '2016-01-08', 'lastUpdatePostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance, usability and ease of use (performance questionnaire)', 'timeFrame': 'Through study completion, estimate average of 1 year', 'description': 'The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer'}], 'secondaryOutcomes': [{'measure': 'Safety (adverse and severe adverse events)', 'timeFrame': 'Through study completion, estimate average of 1 year', 'description': 'Establish safety of the device by measure of adverse and severe adverse events, if such occur.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Diseases']}, 'descriptionModule': {'briefSummary': "Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology", 'detailedDescription': "The investigational devices are EndoChoice gastrointestinal endoscopic systems that are similar in their fit, form, and functions to the corresponding commercially available models with the exception of the EndoChoice's proprietary Optical system that enhances their field of view."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and Female patients ages of 18-75\n* The patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance.\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.\n* Patients who are unable to consent\n* Pregnant female patients of any age."}, 'identificationModule': {'nctId': 'NCT02651857', 'briefTitle': 'Exploratory Study of Upper and Lower Endoscopic Fuse System', 'organization': {'class': 'INDUSTRY', 'fullName': 'EndoChoice Inc.'}, 'officialTitle': 'Exploratory Study of Upper and Lower Endoscopic Fuse System', 'orgStudyIdInfo': {'id': 'Exploratory study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endoscopy exploratory single arm', 'interventionNames': ['Device: Fuse® Colonoscope', 'Device: Fuse® Gastroscope']}], 'interventions': [{'name': 'Fuse® Colonoscope', 'type': 'DEVICE', 'description': 'Endoscopic diagnostic procedures for lower GI tract', 'armGroupLabels': ['Endoscopy exploratory single arm']}, {'name': 'Fuse® Gastroscope', 'type': 'DEVICE', 'description': 'Endoscopic diagnostic procedures for upper GI tract', 'armGroupLabels': ['Endoscopy exploratory single arm']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EndoChoice Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}