Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-30 @ 10:16 AM
Study NCT ID:
NCT05822635
Status:
COMPLETED
Last Update Posted:
2025-01-08
First Post:
2023-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SpyGlass Surgical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2023-04-07', 'studyFirstSubmitQcDate': '2023-04-07', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'During study procedure', 'description': 'Perform intraoperative endoscopy as intended using a thin, single-use, flexible cholangiopancreatoscope as desired, including but not limited to:\n\n* Direct visualization of target lesion or stricture\n* Obtaining biopsies\n* Initiating and/or completing stone clearance'}], 'secondaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': '1 month', 'description': 'Serious adverse events related to the study device, accessory devices used throughout the working channel of the SpyGlass™ system, or the intraoperative endoscopy procedure'}, {'measure': 'Endoscopist rating of clinical impact of study procedure', 'timeFrame': 'During study procedure', 'description': 'Characterization and rating of the clinical benefit and impact of intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope to the surgical procedure on a 1 (highly dissatisfied) to 10 (highly satisfied) scale'}, {'measure': 'Adequate diagnostic yield', 'timeFrame': '1 month', 'description': 'Adequate diagnostic yield of tissue biopsy for histopathology assessment'}, {'measure': 'Endoscopist rating of device', 'timeFrame': 'During study procedure', 'description': 'Rating of the intraoperative performance of the SpyGlass™ system and accessories during intraoperative endoscopy procedure compared to marketed reusable endoscopes on a 1 (highly dissatisfied) to 10 (highly satisfied) scale:\n\n1. Image quality\n2. Ability to irrigate field of view through the irrigation channels\n3. Ability to aspirate through the working channel\n4. Ability to retroflex\n5. Ability to obtain targeted biopsies using biopsy forceps\n6. Ability to grasp stones using wire basket\n7. Ability to perform lithotripsy\n8. Ability to advance accessories through catheter\n9. Ability to selectively advance into targeted ducts'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pancreatic Diseases', 'Bile Duct Diseases', 'Hepatic Disease']}, 'descriptionModule': {'briefSummary': '* To document the clinical utility of diagnostic and/or therapeutic intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope\n* To identify specific surgical procedures in which intraoperative use of a thin, single use, flexible cholangiopancreatoscope suggests clinically meaningful benefit and generate a hypothesis for possible subsequent claims-supportive study', 'detailedDescription': 'This case series aims to document the clinical utility of intraoperative endoscopy using a thin, disposable, flexible cholangiopancreatoscope in procedures including but not limited to:\n\n* Evaluation of biliary lesion(s) during surgical management of common bile duct (CBD) and intrahepatic duct (IHD) strictures, with or without biopsy\n* Transcystic/transcholedochal clearance of biliary stone(s)/sludge/cast with or without mechanical, electrohydraulic or laser lithotripsy\n* Treatment of hepatolithiasis\n* Assessment of communication between the biliary tree and the cyst in the setting of ruptured hydatid parasitic cysts or abcesses\n* Visualization of intraductal papillary mucinous neoplasm (IPMN) lesion(s) with or without biopsy\n* Assessment of pancreatic duct (PD) strictures in chronic pancreatitis, with or without biopsy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with complex pancreaticobiliary disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical indication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope\n* Written informed consent from patient or legally authorized representative of the patient\n\nExclusion Criteria:\n\n* Contraindication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope\n* \\<18 years of age\n* Potentially vulnerable subjects, including, but not limited to pregnant women'}, 'identificationModule': {'nctId': 'NCT05822635', 'briefTitle': 'SpyGlass Surgical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Intraoperative Endoscopy Using a Thin, Single-Use, Flexible Cholangiopancreatoscope', 'orgStudyIdInfo': {'id': 'E7161'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects with complex pancreaticobiliary disease', 'description': 'All subjects will undergo the intraoperative endoscopy with either the SpyGlass Discover System or the SpyGlass DS Direct Visualization System.', 'interventionNames': ['Device: SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System']}], 'interventions': [{'name': 'SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System', 'type': 'DEVICE', 'description': 'Observational, prospective study for the clinical utility of the SpyGlass Discover Digital Catheter and the SpyScope DS Catheter during an intraoperative endoscopy procedure.', 'armGroupLabels': ['Subjects with complex pancreaticobiliary disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Health', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '730000', 'city': 'Lanzhou', 'state': 'Gansu', 'country': 'China', 'facility': 'Lanzhou University No. 1 Hospital', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '999077', 'city': 'Shatin', 'state': 'New Territories', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}, {'zip': '500032', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'Asian Institute of Gastroenterology', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}