Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT05954767
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2023-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C543903', 'term': 'IS 001'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 237}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-28', 'studyFirstSubmitDate': '2023-06-01', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible after second injection', 'timeFrame': '10 minutes', 'description': 'Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging compared white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes'}, {'measure': 'Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible after second injection', 'timeFrame': '30 minutes', 'description': 'Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging compared white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes'}, {'measure': 'Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible after second injection', 'timeFrame': '45 minutes', 'description': 'Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging compared white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes'}, {'measure': 'Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length after second injection', 'timeFrame': '10 minutes', 'description': 'Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode after second injection for procedures lasting longer than 60 minutes'}, {'measure': 'Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length after second injection', 'timeFrame': '30 minutes', 'description': 'Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode after second injection for procedures lasting longer than 60 minutes.'}, {'measure': 'Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length after second injection', 'timeFrame': '45 minutes', 'description': 'Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode after second injection for procedures lasting longer than 60 minutes.'}, {'measure': "Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible - 2nd injection", 'timeFrame': '10 minutes', 'description': "Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging over white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes"}, {'measure': "Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible - 2nd injection", 'timeFrame': '30 minutes', 'description': "Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging over white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes"}, {'measure': "Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible - 2nd injection", 'timeFrame': '45 minutes', 'description': "Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging over white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes"}], 'primaryOutcomes': [{'measure': 'Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible.', 'timeFrame': '10 minutes', 'description': 'Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after IS-001 injection'}, {'measure': 'Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible', 'timeFrame': '30 minutes', 'description': 'Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 30 minutes after IS-001 injection'}], 'secondaryOutcomes': [{'measure': 'Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length', 'timeFrame': '10', 'description': 'Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after injection'}, {'measure': 'Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length', 'timeFrame': '30', 'description': 'Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 30 minutes after injection'}, {'measure': "Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible", 'timeFrame': '10 minutes', 'description': "Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after IS-001 injection"}, {'measure': "Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible", 'timeFrame': '30 minutes', 'description': "Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 30 minutes after IS-001 injection"}, {'measure': 'Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible', 'timeFrame': '45 minutes', 'description': 'Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 45 minutes after IS-001 injection'}, {'measure': 'Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length', 'timeFrame': '45 minutes', 'description': 'Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 45 minutes after IS-001 injection'}, {'measure': "Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible", 'timeFrame': '45 minutes', 'description': "Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 45 minutes after IS-001 injection"}, {'measure': 'Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode', 'timeFrame': '10 minutes', 'description': 'Evaluate ureter signal-to-background ratio in Firefly imaging across time points at (a) the pelvic brim location and (b) the uterine arteries location after IS-001 injection.'}, {'measure': 'Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode', 'timeFrame': '30 minutes', 'description': 'Evaluate ureter signal-to-background ratio in Firefly imaging across time points at (a) the pelvic brim location and (b) the uterine arteries location after IS-001 injection.'}, {'measure': 'Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode', 'timeFrame': '45 minutes', 'description': 'Evaluate ureter signal-to-background ratio in Firefly imaging across time points at (a) the pelvic brim location and (b) the uterine arteries location after IS-001 injection.'}, {'measure': 'concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment', 'timeFrame': '10 minutes', 'description': 'Determine degree of concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment at (a) the pelvic brim location and (b) the uterine arteries location'}, {'measure': 'concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment', 'timeFrame': '30 minutes', 'description': 'Determine degree of concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment at (a) the pelvic brim location and (b) the uterine arteries location'}, {'measure': 'concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment', 'timeFrame': '45 minutes', 'description': 'Determine degree of concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment at (a) the pelvic brim location and (b) the uterine arteries location'}, {'measure': 'Determine degree of concordance of ureter visualization between independent readers', 'timeFrame': '10 minutes', 'description': 'Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim location and (b) the uterine arteries location'}, {'measure': 'Determine degree of concordance of ureter visualization between independent readers', 'timeFrame': '30 minutes', 'description': 'Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim location and (b) the uterine arteries location'}, {'measure': 'Determine degree of concordance of ureter visualization between independent readers', 'timeFrame': '45 minutes', 'description': 'Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim location and (b) the uterine arteries location'}, {'measure': 'degree of concordance of ureter visualization within independent readers', 'timeFrame': '10 minutes', 'description': 'Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim location and (b) the uterine arteries location'}, {'measure': 'degree of concordance of ureter visualization within independent readers', 'timeFrame': '30 minutes', 'description': 'Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim location and (b) the uterine arteries location'}, {'measure': 'degree of concordance of ureter visualization within independent readers', 'timeFrame': '45 minutes', 'description': 'Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim location and (b) the uterine arteries location'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ureter Injury']}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.', 'detailedDescription': 'Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a well-known and serious complication of pelvic and abdominal surgery that frequently goes unrecognized intraoperatively. This study seeks to evaluate the safety and efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'biological', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria\n\n1. Female subject is between the ages of 18 and 75, inclusive.\n2. Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® surgical system with Firefly® fluorescent imaging.\n3. Subject is willing and able to provide informed consent.\n\nExclusion Criteria:\n\n1. Subject is pregnant or nursing.\n2. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n3. Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months\n4. Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile.\n5. Subject has a known or suspected hypersensitivity to indocyanine green (ICG)\n6. Subject has any of the following screening laboratory values:\n\n 1. Estimated glomerular filtration rate (eGFR) \\< 60 mL/min/1.73 m\\^2\n 2. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × upper limit normal (ULN)\n 3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × upper limit normal (ULN).'}, 'identificationModule': {'nctId': 'NCT05954767', 'briefTitle': 'IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intuitive Surgical'}, 'officialTitle': 'A Phase 3 Multi-Center Efficacy Study of IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging', 'orgStudyIdInfo': {'id': 'ISI-124804-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Efficacy', 'description': 'Single intravenous injection of IS-001 and ureter visualization and delineation will be compared in white light standard of care and near-infrared (NIR) imaging mode.', 'interventionNames': ['Drug: IS-001']}], 'interventions': [{'name': 'IS-001', 'type': 'DRUG', 'description': 'IV injection of IS-001 drug substance with near infrared (NIR) imaging', 'armGroupLabels': ['Efficacy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vianh Truong', 'role': 'CONTACT', 'email': 'vianh.truong@hoag.org', 'phone': '949-764-5597', 'phoneExt': '45597'}, {'name': 'Marc Winter, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hoag Memorial Hospital Presbyterian', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Deborah Kisko', 'role': 'CONTACT', 'email': 'Deborah.Kisko@HCAHealthcare.com', 'phone': '305-285-2961'}, {'name': 'Ricardo Estape, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HCA Mercy Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leticia Morales, MHA, CCRP', 'role': 'CONTACT', 'email': 'Leticia.Morales@orlandohealth.com', 'phone': '321-841-9623'}, {'name': 'Jessica Vaught, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Courtney Paradise, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Orlando Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '48912', 'city': 'Lansing', 'state': 'Michigan', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'E.W. Sparrow Hospital', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christian Rodriguez Del Toro', 'role': 'CONTACT', 'email': 'christian.rodriguezdeltoro@hcahealthcare.com', 'phone': '702-856-9352'}, {'name': 'Darin Swainston, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MountainView Hospital', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kayla Diaz', 'role': 'CONTACT', 'email': 'Kayla.diaz@osumc.edu', 'phone': '614-293-8549'}, {'name': 'Casey Cosgrove, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Ohio State Unversity', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "Christina O'Connor", 'role': 'CONTACT', 'email': 'christina.fischer@ohiohealth.com', 'phone': '614-788-3884'}, {'name': 'Anita Somani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'OhioHealth', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '78681', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Krishna Saini', 'role': 'CONTACT', 'email': 'Krishna.Saini@stdavids.com', 'phone': '512-544-8070'}, {'name': 'Devin Garza, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. David's Surgical Hospital", 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '79911', 'city': 'El Paso', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rose Mc Daniel', 'role': 'CONTACT', 'email': 'rose.mcdaniel@tenethealth.com', 'phone': '915-877-8612'}, {'name': 'Richard Farnam, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Hospital of Providence Transmountain Campus', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}], 'centralContacts': [{'name': 'Karen Hwang', 'role': 'CONTACT', 'email': 'karen.hwang@intusurg.com', 'phone': '1-800-876-1310'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intuitive Surgical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}