Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2026-01-05 @ 3:53 AM
Study NCT ID:
NCT03685903
Status:
UNKNOWN
Last Update Posted:
2020-05-29
First Post:
2018-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D053705', 'term': 'Capsule Endoscopes'}], 'ancestors': [{'id': 'D020776', 'term': 'Endoscopes, Gastrointestinal'}, {'id': 'D019723', 'term': 'Endoscopes'}, {'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2018-09-24', 'studyFirstSubmitQcDate': '2018-09-24', 'lastUpdatePostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The ability to detect and visualize the duodenal papilla', 'timeFrame': 'during capsule endoscopy procedure', 'description': 'Rate of duodenal papilla detection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Patients Indicated for Periampullary or Pancreaticobiliary Examination']}, 'descriptionModule': {'briefSummary': 'This observational Non-Significant Risk (NSR) Study will be used to assess the ability of CapsoCam® Plus (SV-3) capsule endoscope to detect the duodenal papilla and visualize pathology or abnormalities in the periampullary area and will prospectively compare the capsule endoscopy and EUS/ERCP pictorial images acquired in procedures conducted in a minimum of 20 and a maximum of 200 research patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females at least 18 years of age.\n* Provided written HIPAA Informed Consent in the IRB approved language.\n* Patients indicated for periampullary or pancreaticobiliary examination, with prior cross-sectional imaging (CT/MRI/US/other) performed within past 6 months.\n\nExclusion Criteria:\n\n* Patients with existing biliary stent will be excluded\n* EUS/ERCP exclusion criteria: per medical practice, including:\n\n 1. Patient refusal to undergo procedure, unstable cardiopulmonary, neurologic, or cardiovascular status; existing bowel perforation\n 2. Structural abnormalities of esophagus, stomach, small intestine at the discretion of physician.\n* Capsule Endoscopy (CE) exclusion criteria:\n\n 1. CE exclusion criteria: difficulty swallowing, pregnancy, known motility issues (gastroparesis), known strictures, gastrointestinal obstructions, fistula or significantly distorted anatomy.\n 2. Medical history of receipt of surgery, oncologic therapy, or radiation therapy who, in the opinion of the investigator, are at greater risk of capsule endoscope retention.\n 3. Any other contra-indicated condition as noted on the CapsoCam® Plus (SV-3) Instructions for Use, package insert.'}, 'identificationModule': {'nctId': 'NCT03685903', 'briefTitle': 'Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Capso Vision, Inc.'}, 'officialTitle': 'Prospective Observational Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure in Pancreaticobiliary and Periampullary Pathology', 'orgStudyIdInfo': {'id': 'CLN-CVI-4801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CapsoCam® Plus (SV-3) capsule endoscope', 'description': 'Endoscope Capsule', 'interventionNames': ['Device: CapsoCam® Plus (SV-3) capsule endoscope']}], 'interventions': [{'name': 'CapsoCam® Plus (SV-3) capsule endoscope', 'type': 'DEVICE', 'description': 'Endoscope Capsule', 'armGroupLabels': ['CapsoCam® Plus (SV-3) capsule endoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capso Vision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}