Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-27 @ 10:14 PM
Study NCT ID:
NCT04494295
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2020-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2020-07-28', 'studyFirstSubmitQcDate': '2020-07-28', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Surgical Success', 'timeFrame': 'During surgical procedure to evacuate supratentorial intracerebral hemorrhage', 'description': 'Rate of surgical success defined as reduction to \\< 15 cc total volume of the supratentorial intracerebral hemorrhage on immediate Post-op CT Scan'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Supratentorial Hemorrhage']}, 'descriptionModule': {'briefSummary': 'This registry will study the use of the Aurora® Surgiscope to provide surgical access and visualization in minimally invasive removal of hematoma in the brain. Many methods of hematoma removal are available and will be based on surgeon preference. The impact of patient selection and time to surgery from last known well time will be explored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'general population with an acute, spontaneous, primary, supratentorial ICH', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject Age is \\> 18\n* Subject with a Head CT that demonstrates an acute, spontaneous, primary, supratentorial ICH of volume \\> 20 mL, assessed via standard of care techniques\n* Subject Surgery can be initiated within 24 hours of the last known well time or, in patients with wake-up onset, within 24 hours of the time the patient awoke with symptoms.\n* Subject has a NIHSS score \\> 5\n* Subject has a baseline Modified Rankin Scale (mRS) Score ≤ 2\n* Subject with a CT Angiography demonstrating no vascular malformation\n\nExclusion Criteria:\n\n* Subject has an underlying vascular lesion defined as causative source of ICH\n* Subject has a profound neurological deficit defined as fixed/dilated pupils or bilateral extensor motor posturing\n* Subject has an Infratentorial or brainstem ICH\n* Subject has a known life expectancy \\< 6 months\n* Subject has an uncorrectable coagulopathy\n* Subject has a mechanical heart valve\n* Subject is pregnant\n* Subject participates in another concurrent interventional clinical trial\n* Subject who is unable to meet study follow-up requirements'}, 'identificationModule': {'nctId': 'NCT04494295', 'acronym': 'MIRROR', 'briefTitle': 'The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integra LifeSciences Corporation'}, 'officialTitle': 'The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation', 'orgStudyIdInfo': {'id': 'C-MIRROR-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AURORA', 'description': 'Aurora® Surgiscope used for MIS evacuation of supratentorial hematoma', 'interventionNames': ['Device: Aurora Surgiscope System']}], 'interventions': [{'name': 'Aurora Surgiscope System', 'type': 'DEVICE', 'description': 'MIS evacuation of hematoma using the Aurora Surgiscope System', 'armGroupLabels': ['AURORA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91505', 'city': 'Burbank', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Figueroa', 'role': 'CONTACT', 'email': 'Jeffrey.Figueroa@providence.org'}, {'name': 'Adi Iyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Providence Health', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adriana Saravia', 'role': 'CONTACT', 'email': 'a.saravia@med.miami.edu'}, {'name': 'Adib Abla, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shardonnai Sims', 'role': 'CONTACT', 'email': 'shardonnaisims@tgh.org'}, {'name': 'Kunal Vakharia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca McWilliams', 'role': 'CONTACT', 'email': 'rebecca_mcwilliams@rush.edu'}, {'name': 'R. Webster Crowley, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cynthia Yashinki', 'role': 'CONTACT'}, {'name': 'Rocco Armonda, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MedStar Health Research Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'TERMINATED', 'country': 'United States', 'facility': 'Corewell Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brooke Hoffman', 'role': 'CONTACT', 'email': 'hoffmanba@health.missouri.edu'}, {'name': 'Michael Chicoine, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ramie Heo', 'role': 'CONTACT', 'email': 'heor@wustl.edu'}, {'name': 'Joshua Osbun, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08820', 'city': 'Edison', 'state': 'New Jersey', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Surekha Patel, MBBS', 'role': 'CONTACT'}, {'name': 'Brian Jankowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'JFK university', 'geoPoint': {'lat': 40.51872, 'lon': -74.4121}}, {'zip': '14260', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michaela Laskowski', 'role': 'CONTACT', 'email': 'mlaskowski@ubns.com'}, {'name': 'Adnan Siddiqui, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University at Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily Svendsen', 'role': 'CONTACT', 'email': 'emily.svendsen@mountsinai.org'}, {'name': 'Tomoyoshi Shigematsu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599-1350', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patricia Orozco', 'role': 'CONTACT'}, {'name': 'Edward Yap, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joyce Barmen', 'role': 'CONTACT', 'email': 'barmenj2@ccf.org'}, {'name': 'Mark Bain, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Omini', 'role': 'CONTACT', 'email': 'michael-omini@ouhsc.edu'}, {'name': 'Andrew Bauer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Olivia Christman', 'role': 'CONTACT'}, {'name': 'Ephraim Church, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pennsylvania State University', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'TERMINATED', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29601', 'city': 'Greenville', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rosie Gaddy', 'role': 'CONTACT', 'email': 'rosie.gaddy@prismahealth.org'}, {'name': 'Jan Varas Machaj, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prisma Health - Upstate', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrea Gaitan', 'role': 'CONTACT', 'email': 'Andrea.BecerrilGaitan@uth.tmc.edu'}, {'name': 'Jared Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UT Health', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Do Lim', 'role': 'CONTACT', 'email': 'dolim@uw.edu'}, {'name': 'Michael Levitt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Washington - Harborview', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Habib Nacer-Chérif', 'role': 'CONTACT', 'email': 'habib.nacercherif@integralife.com', 'phone': '+33626190029'}], 'overallOfficials': [{'name': 'Sigmund Kulessa', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Integra LifeSciences Corporation'}, {'name': 'Christopher Kellner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integra LifeSciences Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, {'name': 'Oculus Imaging LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}