RenovoCath®
DeviceIntra-arterial catheter delivery of chemotherapy agents for the collection of real-world data.
NCT Number: NCT06805461
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Baptist Health South Florida, Coral Gables, Florida, United States
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.
This observational post-marketing registry study is intended to track the safety and performance of the RenovoCath® device and assess patient survival / 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/or 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Eligibility Criteria:
Intra-arterial catheter delivery of chemotherapy agents for the collection of real-world data.
Time frame: From the time of the first treatment, until 30 days after the last treatment
Number of participants experiencing adverse events related to the chemotherapy agents administered using RenovoCath.
Time frame: From the time of the first treatment, until 30 days after the last treatment
Track the performance of RenovoCath® in a real-world setting delivering a variety of therapeutic agents
Time frame: 24 months from date of first treatment with IA
Evaluate overall survival (OS) in patients diagnosed with solid tumors who undergo localized IA delivery of therapeutic agents via the RenovoCath®
Time frame: 24 months from date of first treatment with IA
Assess tumor response, via imaging, in the primary site of application
Time frame: 6 months from the date of the first IA treatment
The number of participants who received IA treatment with RenovoCath and later receive resection of their tumor
Contact information is provided by the study sponsor or research team.
Leesa M Gentry
CONTACT
Nicolette G Keller
CONTACT
RenovoRx
Industry
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
Acronym: PumaRx
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03486873
Hematologic Diseases, Hematologic Malignancies
Tucson, Arizona, United States
View Trial DetailsNCT07492680
Brain Diseases, Brain Neoplasms
San Francisco, California, United States
View Trial DetailsNCT05503797
Adenocarcinoma, Adnexal Diseases
Beverly Hills, California, United States
View Trial DetailsNCT07415031
Solid Tumors
Phoenix, Arizona, United States
View Trial Details