[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06805461":3,"trial-entities:NCT06805461":111,"trial-summary:NCT06805461":115},{"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":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":43,"sex":55,"minimum_age":56,"maximum_age":23,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":61,"locations":64,"central_contacts":100,"overall_officials":108,"references":109,"see_also_links":110},"NCT06805461","RR5","PumaRx Registry Trial","A Multi-Center, Observational, Post-Marketing, Registry Study Following Patients With Solid Tumors Treated With Therapeutic Agents Via Localized Intra-Arterial Delivery Using the RenovoCath® Catheter","RECRUITING","2029-09-03","2025-10","2026-03-30","2025-08-01","RenovoRx","INDUSTRY",false,"This study is a multicenter, observational, post-marketing, registry study designed to track the safety and performance of the RenovoCath® device and assess survival outcomes in patients diagnosed with solid tumors who are treated with localized intra-arterial (IA) delivery of therapeutic agents to solid tumors using the RenovoCath® catheter.","This study will enroll patients diagnosed with solid tumors who are willing to participate in the registry and meet the study enrollment criteria. Participants will be treated with therapeutic agents using RenovoCath® for the approved intended use according to the current country-specific Instructions for Use (IFU). Participants will be followed for survival outcome. Patients may chose to consent to participation in the registry before, during, or after treatment with the RenovoCath® device.\n\nThis observational post-marketing registry study is intended to track the safety and performance of the RenovoCath® device and assess patient survival \u002F clinical outcomes of RenovoCath® in a real-world, clinical, observational setting when used for targeted delivery of therapeutic agents. Up to 1000 patients will be enrolled at up to an estimated 100 sites. Each patient participating in the registry study will have medical record retrievals including past data as of the time of their initial diagnosis through all localized IA administrations of therapeutic agent(s) using RenovoCath®, with continued record retrieval through the end of patient follow-up to record mortality rates. Patient data collection will include prior treatment history. Patients and\u002For their families will be contacted periodically after the treatment(s) to assess survival. It is anticipated that each participating patient's records will be retrieved approximately four times throughout the course of their treatment and follow-up, or retrospectively should patents decide to participate in the registry upon the completion of their treatment or during follow-up. This registry study is expected to continue for six years from study commencement.",[19],"Solid Tumors",[21],"Intra-Arterial Catheter","OBSERVATIONAL",null,[],{"count":26,"type":27},1000,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","RenovoCath®","Intra-arterial catheter delivery of chemotherapy agents for the collection of real-world data.",[34],"Patients receiving Intra-Arterial treatment with RenovoCath",[36,40],{"measure":37,"description":38,"timeFrame":39},"Safety of RenovoCath® as assessed by the number of participants experiencing adverse events related to the chemotherapy agents administered using RenovoCath.","Number of participants experiencing adverse events related to the chemotherapy agents administered using RenovoCath.","From the time of the first treatment, until 30 days after the last treatment",{"measure":41,"description":42,"timeFrame":39},"Performance of RenovoCath® as assessed by the number of participants experiencing adverse events related to the inter-arterial drug delivery procedure.","Track the performance of RenovoCath® in a real-world setting delivering a variety of therapeutic agents",[44,48,51],{"measure":45,"description":46,"timeFrame":47},"Overall Survival","Evaluate overall survival (OS) in patients diagnosed with solid tumors who undergo localized IA delivery of therapeutic agents via the RenovoCath®","24 months from date of first treatment with IA",{"measure":49,"description":50,"timeFrame":47},"Tumor Response Rate","Assess tumor response, via imaging, in the primary site of application",{"measure":52,"description":53,"timeFrame":54},"Number of participants who are downstaged and have their tumor resected after IA treatment with RenovoCth","The number of participants who received IA treatment with RenovoCath and later receive resection of their tumor","6 months from the date of the first IA treatment","ALL","18 Years",{"inclusion":58,"exclusion":59,"raw_text":60},[],[],"Eligibility Criteria:\n\n1. Male and female patients who have been diagnosed with solid tumor cancers and are at least 18 years of age at the time of the first IA procedure\n2. Patients willing to provide informed consent and HIPAA release for use of their relevant medical records",[62,63],"ADULT","OLDER_ADULT",[65,78,89],{"facility":66,"status":8,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":75},"Baptist Health South Florida","Coral Gables","Florida","33143","United States",[72],{"name":73,"role":74},"Dr. Gandhi","CONTACT",{"lat":76,"lon":77},25.72149,-80.26838,{"facility":79,"status":8,"city":80,"state":81,"zip":82,"country":70,"contacts":83,"geoPoint":86},"University of Pennsylvania Medical Center","Pittsburgh","Pennsylvania","15213",[84],{"name":85,"role":74},"Dr. Novelli",{"lat":87,"lon":88},40.44062,-79.99589,{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":70,"contacts":94,"geoPoint":97},"The University of Vermont Medical Center","Burlington","Vermont","05401",[95],{"name":96,"role":74},"Dr. O'Neill",{"lat":98,"lon":99},44.47588,-73.21207,[101,105],{"name":102,"role":74,"phone":103,"email":104},"Leesa M Gentry","650-284-4433","lgentry@renovorx.com",{"name":106,"role":74,"phone":103,"email":107},"Nicolette G Keller","nkeller@renovorx.com",[],[],[],{"nct_id":4,"conditions":112,"biomarkers":114},[113],"Solid Neoplasm",[],{"nct_id":4,"found":116,"summary":117,"prompt_version":127},true,{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is an observational study, meaning researchers will collect information about your care without influencing your treatment decisions. Up to 1000 participants will be enrolled.","completed","PumaRx Registry Trial for Solid Tumors","This study is an observational registry looking at the RenovoCath® device, which helps deliver chemotherapy directly to solid tumors. It's designed to track how safe and effective RenovoCath® is in a real-world setting. Researchers will be looking at any side effects from the chemotherapy delivered by RenovoCath®, as well as any issues related to the delivery procedure itself. You might be able to join if you are at least 18 years old, have been diagnosed with a solid tumor, and are willing to share your medical records. The study aims to enroll up to 1000 people. The current recruitment status is unclear.","You will be followed for survival outcomes. Safety and performance will be assessed from the first treatment until 30 days after the last treatment.",102,"You would provide informed consent and allow researchers to access your medical records, including past treatment history. You or your family may be contacted periodically to check on your survival.","Not stated in the trial record.",[31],"v2"]