[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05110989":3,"trial-entities:NCT05110989":215,"trial-summary:NCT05110989":219},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":15,"phases":21,"enrollment_info":22,"interventions":25,"primary_outcomes":30,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":15,"healthy_volunteers":41,"eligibility_criteria":42,"std_ages":46,"locations":50,"central_contacts":202,"overall_officials":211,"references":213,"see_also_links":214},"NCT05110989","REDUCE2018","A Multicenter Patient Registry on Outcomes From Cryoanalgesia of the Intercostal Nerves","The CryoICE™ Cryoanalgesia Registry for Pain Management in Post-cardiothoracic Surgery Via Cryoablation of the Intercostal Nerves","RECRUITING","2040-01","2026-06","2026-06-29","2018-06-29","AtriCure, Inc.","INDUSTRY",null,"This is a retrospective and prospective, multicenter, observational patient registry to record outcomes from patients undergoing cryoablation of the intercostal nerves (cryoanalgesia) for post-operative pain management.",[18],"Post Operative Pain",[],"OBSERVATIONAL",[],{"count":23,"type":24},5000,"ESTIMATED",[26],{"type":27,"name":28,"description":29},"DEVICE","AtriCure Cryo Nerve Block (cryoNB) Device Family","Use of Atricure Cryo Nerve Block Device Family to generate cryoanalgesia for the management of post operative pain.",[31,35],{"measure":32,"description":33,"timeFrame":34},"Efficacy of cryo nerve block to generate cryoanalgesia as post operative pain management","Collect pain score to assess the effect of cryoanalgesia effect with a follow up duration of up to 5 years.","From enrollment to 5 years after date of index procedure",{"measure":36,"description":37,"timeFrame":34},"Safety of cryo nerve block to generate cryoanalgesia as post operative pain management","Collect adverse events occurred during and post operation to assess the safety of the cryo nerve block procedure.",[],"ALL","12 Years",false,{"inclusion":43,"exclusion":44,"raw_text":45},[],[],"Inclusion Criteria:\n\n1. Patients whose age is 12 years or above, and are able to give informed consent\u002Fassent specific to state and national law.\n2. Patients have been scheduled by physician(s) to undergo or have undergone cryoablation of the intercostal nerves utilizing at least one AtriCure device or are similar patients treated without the use of cryoablation\n\nExclusion Criteria:\n\n1. Patient is enrolled in a concurrent trial that may impact the treatment offered by the registry devices.\n2. Patient with exclusion criteria required by local governance.\n3. Women of childbearing potential who are, or plan to become, pregnant during the time of the study",[47,48,49],"CHILD","ADULT","OLDER_ADULT",[51,69,83,96,105,116,131,146,160,174,188],{"facility":52,"status":8,"city":53,"state":54,"zip":55,"country":56,"contacts":57,"geoPoint":66},"Baptist MD Anderson Cancer Center","Jacksonville","Florida","32207","United States",[58,63],{"name":59,"role":60,"phone":61,"email":62},"Brittany Merritt","CONTACT","904-202-7319","brittany.merritt@bmcjax.com",{"name":64,"role":65},"David Hall","PRINCIPAL_INVESTIGATOR",{"lat":67,"lon":68},30.33218,-81.65565,{"facility":70,"status":8,"city":71,"state":54,"zip":72,"country":56,"contacts":73,"geoPoint":80},"AdventHealth","Orlando","32803",[74,78],{"name":75,"role":60,"phone":76,"email":77},"Jessica Injiac","407-303-4265","Jessica.injiac@adventhealth.com",{"name":79,"role":65},"Colleen Gaughan, MD",{"lat":81,"lon":82},28.53834,-81.37924,{"facility":84,"status":8,"city":85,"state":86,"zip":87,"country":56,"contacts":88,"geoPoint":93},"Luminis Health Anne Arundel Medical Center","Annapolis","Maryland","21401",[89],{"name":90,"role":60,"phone":91,"email":92},"David J Caparrelli, MD","443-481-1358","dcaparrell@luminishealth.org",{"lat":94,"lon":95},38.97859,-76.49184,{"facility":97,"status":98,"city":99,"state":100,"zip":101,"country":56,"geoPoint":102},"St. Luke's Hospital of Kansas City","COMPLETED","Kansas City","Missouri","64111",{"lat":103,"lon":104},39.09973,-94.57857,{"facility":106,"status":8,"city":107,"state":108,"zip":109,"country":56,"contacts":110,"geoPoint":113},"Elliot Hospital","Manchester","New Hampshire","03101",[111],{"name":112,"role":60},"Curits Quinn, MD",{"lat":114,"lon":115},42.99564,-71.45479,{"facility":117,"status":8,"city":118,"state":119,"zip":120,"country":56,"contacts":121,"geoPoint":128},"The Christ Hospital","Cincinnati","Ohio","45219",[122,126],{"name":123,"role":60,"phone":124,"email":125},"Katherine Gloria","513-585-1777","Katherineaubre.Glori@thechristhospital.com",{"name":127,"role":65},"Julian Guitron, MD",{"lat":129,"lon":130},39.12711,-84.51439,{"facility":132,"status":8,"city":133,"state":134,"zip":135,"country":56,"contacts":136,"geoPoint":143},"Baylor College of Medicine","Houston","Texas","77030",[137,141],{"name":138,"role":60,"phone":139,"email":140},"Joan Reynoso Rosario, MD","713-798-6119","joan.reynosorosario@bcm.edu",{"name":142,"role":65},"Gabriel Loor, MD",{"lat":144,"lon":145},29.76328,-95.36327,{"facility":147,"status":8,"city":148,"country":149,"contacts":150,"geoPoint":157},"Medical University of Vienna","Vienna","Austria",[151,155],{"name":152,"role":60,"phone":153,"email":154},"Nina Fruhmann","+43(0) 1 40400 56440","nina.fruhmann@meduniwien.ac.at",{"name":156,"role":65},"Clemens Aigner, MD, MBA, FETCS",{"lat":158,"lon":159},48.20849,16.37208,{"facility":161,"status":8,"city":162,"country":163,"contacts":164,"geoPoint":171},"UZ Leuven","Leuven","Belgium",[165,169],{"name":166,"role":60,"phone":167,"email":168},"Céline Rihon","+ 32 16 34 12 13","celine.rihon@uzleuven.be",{"name":170,"role":65},"Hans Van Veer, MD, FEBS-OGSurg",{"lat":172,"lon":173},50.87959,4.70093,{"facility":175,"status":8,"city":176,"country":177,"contacts":178,"geoPoint":185},"University of Heidelberg","Heidelberg","Germany",[179,183],{"name":180,"role":60,"phone":181,"email":182},"Stefanie Lo Giudice","+49 6221 396-8110","stefanie.logiudice@med.uni-heidelberg.de",{"name":184,"role":65},"Hauke Winter",{"lat":186,"lon":187},49.40768,8.69079,{"facility":189,"status":8,"city":190,"country":191,"contacts":192,"geoPoint":199},"University Hospitals Leicester NHS Trust","Leicester","United Kingdom",[193,197],{"name":194,"role":60,"phone":195,"email":196},"Rebecca Boyles","0116 2583370","rebecca.boyles1@nhs.net",{"name":198,"role":65},"Edward Caruana",{"lat":200,"lon":201},52.6386,-1.13169,[203,207],{"name":204,"role":60,"phone":205,"email":206},"Elizabeth Menard","8327120715","REDUCE-REGISTRY@atricure.com",{"name":208,"role":60,"phone":209,"email":210},"Laura O'Brien, PhD","763-310-6151","lobrien@atricure.com",[212],{"name":112,"affiliation":106,"role":65},[],[],{"nct_id":4,"conditions":216,"biomarkers":218},[217],"Post-Operative Pain",[],{"nct_id":4,"found":220,"summary":221,"prompt_version":231},true,{"design":222,"status":223,"heading":224,"summary":225,"follow_up":226,"word_count":227,"commitments":228,"compensation":229,"drugs_mentioned":230},"This is an observational study that plans to include 5000 participants. It will collect information both from past records and from people currently undergoing treatment.","completed","Observational Study of Cryoanalgesia for Post-Operative Pain","This study is looking at how well a treatment called cryoanalgesia works for managing pain after surgery. Cryoanalgesia uses a device called the AtriCure Cryo Nerve Block to freeze intercostal nerves (nerves between your ribs) to reduce pain. Researchers want to see how effective and safe this treatment is over a period of up to five years. You might be able to join if you are 12 years or older and are scheduled to have or have already had this cryoablation procedure, or a similar procedure without cryoablation. This is an observational study, meaning researchers will collect information about your experience rather than giving you a new treatment.","Participants will be followed from their enrollment date for up to 5 years after their procedure to assess the treatment's effectiveness and safety.",108,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]