[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544929":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":22,"centralContacts":29,"locations":39,"responsibleParty":70,"collaborators":72,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":22,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":22,"enrollmentInfo":87,"targetDuration":22,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":42,"whyStopped":22,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Restorear Devices LLC","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Safety Study","EXPERIMENTAL","Aim 1: Ascertain the safety of the system and device in patients undergoing cochlear implantation (CI). Mild therapeutic hypothermia will be delivered to the subjects during CI surgery via the ear canal.",[13],"Device: Intra-Ear Canal Cooling Catheter",{"label":15,"type":10,"description":16,"interventionNames":17},"Efficacy Study Cooling","Aim 2: Ascertain the applicability and efficacy of the device and system in patients undergoing cochlear implantation (CI). Half of the candidates will receive mild therapeutic hypothermia via the ear canal during cochlear implant surgery.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Efficacy Study Control","NO_INTERVENTION","Aim 2: Ascertain the applicability and efficacy of the device and system in patients undergoing cochlear implantation (CI). Half of the candidates will receive standard of care (no cooling) during cochlear implant surgery.",null,[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":22},"DEVICE","Intra-Ear Canal Cooling Catheter","Mild therapeutic hypothermia will be applied via the catheter device installed inside the ear canal by an experienced surgeon during cochlear implantation (CI) surgery.",[15,9],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":22,"email":34},"Suhrud M Rajguru, Ph.D.","CONTACT","801-641-8180","srajguru@restorear.com",{"name":36,"role":32,"phone":37,"phoneExt":22,"email":38},"Curtis S King","406-414-6278","cking@restorear.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of Miami","RECRUITING","Miami","Florida","33136","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-80.19366,25.77427,{"lat":52,"lon":51},[55,57,61,62,64,66,68],{"name":31,"role":32,"phone":56,"phoneExt":22,"email":34},"8016418180",{"name":58,"role":32,"phone":59,"phoneExt":22,"email":60},"Sandra Prentiss, Ph.D., CCC-A","305-890-6059","S.Prentiss@med.miami.edu",{"name":31,"role":32,"phone":22,"phoneExt":22,"email":22},{"name":63,"role":32,"phone":22,"phoneExt":22,"email":22},"Michael Hoffer, M.D.",{"name":65,"role":32,"phone":22,"phoneExt":22,"email":22},"Fred Telischi, M.D.",{"name":67,"role":32,"phone":22,"phoneExt":22,"email":22},"Simon Angeli, M.D.",{"name":69,"role":32,"phone":22,"phoneExt":22,"email":22},"Sandra Prentiss, Ph.D.",{"type":71,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[73,75],{"name":41,"class":74},"OTHER",{"name":76,"class":77},"National Institute on Deafness and Other Communication Disorders (NIDCD)","NIH","100544929","investigation-of-a-device-to-deliver-intra-operative-therapeutic-hypothermia-for-hearing-preservation-in-cochlear-implantation-100544929",false,"NCT06375278","Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation","Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation","Inclusion Criteria:\n\nPotential participants for the study are patients who have been diagnosed with severe to profound hearing loss (HL) and plan to undergo cochlear implantation (CI) at the University of Miami. The cochlear implant surgery, pre and post-surgical care, and activation and programming of the implant are part of the participants' standard of care. If the inclusion criteria are met (age 18 years and older, equal number of men and women, profound sensorineural hearing loss (for safety study n=6) and residual hearing (see criteria below) from pre-surgical auditory brainstem response (ABR) (for efficacy study n=48), equal numbers of CI devices from all 3 manufactures and English or Spanish speakers the patient will be approached by the study personnel and will be asked to participate in the study.\n\nExclusion Criteria:\n\nSubjects under 18 years of age. Subjects not meeting functional hearing requirements.\n\nTypes of CI devices:\n\nThe study will enroll patients receiving CI devices from all three manufactures.\n\n1. Advanced Bionics (FDA indications - severe to profound sensorineural hearing loss (greater than or equal to 70 dB HL)\n\n   1. HiRes Ultra 3D slim J\n   2. HiRes Ultra 3D midScala\n2. Cochlear Corporation (FDA indications - moderate to profound sensorineural hearing loss; sentence recognition less than or equal to 50% in the ear to be implanted AND less than or equal to 60% in the contralateral ear\n\n   1. CI632\n   2. CI622\n   3. CI612\n3. Med-EL (moderately-severe to severe sensorineural hearing loss (greater than or equal to 65 db HL).\n\n   1. Synchrony 2 Flex soft\n   2. Synchrony 2 Flex28\n   3. Synchrony 2 Flex 24\n   4. Synchrony 2 Compressed\n   5. Synchrony 2 Medium\n\nAdditional patients receiving devices not listed here may be eligible as the criteria by manufacturer change.","ALL","18 Years",{"count":88,"type":89},54,"ESTIMATED","INTERVENTIONAL",[92],"NA","The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are:\n\n1. Is mild therapeutic hypothermia safe for use during cochlear implantation?\n2. Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation?\n\nParticipants will receive mild therapeutic hypothermia therapy during cochlear implant surgery. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy).",[95,96,97],"Cochlear Implants","Cochlear Implantation","Hearing Loss",[99,100,101],"Cochlear Implant","Residual Hearing","Hearing Preservation","2024-11-18",{"date":104,"type":105},"2024-11-21","ACTUAL",{"date":107,"type":105},"2024-09-23",{"date":109,"type":89},"2026-07-31",{"name":5,"class":6},1]