Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-20 @ 4:46 PM
Study NCT ID:
NCT03701958
Status:
COMPLETED
Last Update Posted:
2022-02-08
First Post:
2018-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Case Series With Exalt Single-Use Duodenoscope
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-04', 'studyFirstSubmitDate': '2018-07-31', 'studyFirstSubmitQcDate': '2018-10-08', 'lastUpdatePostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful ERCP procedure', 'timeFrame': 'Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).', 'description': 'The ability to complete the ERCP procedure for the intended indication(s); outcome reported as "success" or "failure". Examples include but are not limited to: biliary stent placement, pancreatic stent placement, sphincterotomy, and clearance of bile duct stones.'}], 'secondaryOutcomes': [{'measure': 'Endoscopist qualitative rating', 'timeFrame': 'Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure (within 24 hours on study day 1).', 'description': 'Endoscopist rating of the Exalt single-use duodenoscope compared to their past experience with marketed reusable duodenoscopes as it pertains to various design and performance related attributes.'}, {'measure': 'Incidence of crossover from Exalt single-use duodenoscope to reusable duodenoscope', 'timeFrame': 'Incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1).', 'description': 'The need to use a reusable duodenoscope for any task which cannot be adequately performed with the Exalt single-use duodenoscope is considered a crossover.'}, {'measure': 'Evaluation of adverse events (SAEs) related to the device and/or the procedure', 'timeFrame': 'SAEs are assessed through 7 days after the procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endoscopic Retrograde Cholangiopancreatography']}, 'referencesModule': {'references': [{'pmid': '31706060', 'type': 'DERIVED', 'citation': 'Muthusamy VR, Bruno MJ, Kozarek RA, Petersen BT, Pleskow DK, Sejpal DV, Slivka A, Peetermans JA, Rousseau MJ, Tirrell GP, Ross AS. Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2108-2117.e3. doi: 10.1016/j.cgh.2019.10.052. Epub 2019 Nov 6.'}]}, 'descriptionModule': {'briefSummary': 'To confirm procedural performance of the Exalt single-use duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures.', 'detailedDescription': 'This study is a prospective, multi-center case series of per standard of care ERCP procedures using a nonsignificant risk single-use duodenoscope. 35-70 cases will be included at up to 10 clinical sites. Patients who meet all eligibility criteria will be included and will have a clinically indicated ERCP procedure performed using the study device. Enrolled subjects will be followed for 7 days after their procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.\n* Scheduled for a clinically indicated ERCP\n\nExclusion Criteria:\n\n* Altered pancreaticobiliary anatomy\n* Potentially vulnerable subjects, including, but not limited to pregnant women\n* Subjects for whom endoscopic techniques are contraindicated\n* Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor\n* Investigator discretion'}, 'identificationModule': {'nctId': 'NCT03701958', 'briefTitle': 'Initial Case Series With Exalt Single-Use Duodenoscope', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Initial Case Series With Exalt Single-Use Duodenoscope', 'orgStudyIdInfo': {'id': 'E7145'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Exalt DScope 01', 'description': 'Subjects will have a clinically indicated per standard of care ERCP procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.', 'interventionNames': ['Device: Exalt Model D Single-Use Duodenoscope']}], 'interventions': [{'name': 'Exalt Model D Single-Use Duodenoscope', 'type': 'DEVICE', 'description': 'Subjects will have a clinically indicated per standard of care ERCP procedure performed with the Exalt single use duodenoscope study device.', 'armGroupLabels': ['Exalt DScope 01']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Reagan University of California Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'V. Raman Muthusamy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}, {'name': 'Andrew Ross, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Mason Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}