Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-03-02 @ 4:00 PM
Study NCT ID:
NCT06282094
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ViSiGi LUX Bariatric Sizing and Calibration System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2024-02-12', 'studyFirstSubmitQcDate': '2024-02-20', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physician Feedback', 'timeFrame': '6 months', 'description': 'The physician provides feedback and comments on the usability of the device. The physician will rate the device on a Likert scale. 1-7 higher score is better'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bariatric Surgery Candidate']}, 'descriptionModule': {'briefSummary': 'This study investigates the new ViSiGi LUX.', 'detailedDescription': 'ViSiGi is used during numerous gastric and bariatric procedures. The new device, ViSiGi LUX functions as the FDA-cleared ViSiGi but has the added visualization of NIR lights.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing gastric or bariatric procedures.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* able to consent\n* candidate for robotic bariatric surgery\n\nExclusion Criteria:\n\n* esophageal stricture that does not allow passage of the device\n* conditions that would preclude gastric or bariatric surgical procedures\n* pregnant patients'}, 'identificationModule': {'nctId': 'NCT06282094', 'briefTitle': 'ViSiGi LUX Bariatric Sizing and Calibration System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Labs LLC'}, 'officialTitle': 'ViSiGi LUX Bariatric Sizing and Calibration System Usability Study', 'orgStudyIdInfo': {'id': 'LUX'}}, 'contactsLocationsModule': {'locations': [{'zip': '17405', 'city': 'York', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Faiz Shariff', 'role': 'CONTACT'}], 'facility': 'WellSpan', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}], 'centralContacts': [{'name': 'Elena Lagunilla', 'role': 'CONTACT', 'email': 'elagunilla@boehringerlabs.com', 'phone': '4849312338'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Labs LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}