An observational study in Solid Tumors, sponsored by RenovoRx. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by RenovoRx · Observational
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.
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.
RenovoRx is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be recruited for the study by treating physicians. Up to 1000 participants may be enrolled at up to an estimated 100 study sites. Participants will have been diagnosed with solid tumors with histological or cytological confirmation and may have been treated previously with chemotherapy, radiation therapy, or other modalities.
Eligibility Criteria:
Patients receiving Intra-Arterial treatment with RenovoCath
Device: RenovoCath®
Intra-arterial catheter delivery of chemotherapy agents for the collection of real-world data.
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.
Time frame: From the time of the first treatment, until 30 days after the last treatment
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
Time frame: From the time of the first treatment, until 30 days after the last treatment
Overall Survival
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
Tumor Response Rate
Assess tumor response, via imaging, in the primary site of application
Time frame: 24 months from date of first treatment with IA
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
Time frame: 6 months from the date of the first IA treatment
Plan to share: No — IPD will be shared with participating investigators only.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
RenovoRx