PumaRx Registry for RenovoCath delivery to solid tumors
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
RenovoRx · NCT06805461
This registry follows adults with solid tumors to track how the RenovoCath catheter performs and how patients do after cancer medicines are delivered directly into tumors through arteries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RenovoRx (industry) |
| Locations | 3 sites (Coral Gables, Florida and 2 other locations) |
| Trial ID | NCT06805461 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, observational post‑marketing registry that records real‑world safety, device performance, and survival outcomes for patients treated with the RenovoCath intra‑arterial catheter. Up to 1,000 adult patients treated per the country‑specific Instructions for Use will be enrolled across an estimated ~100 participating sites. Medical records (including prior treatments and all localized IA administrations with RenovoCath) will be retrieved about four times and patients or families will be contacted periodically to capture survival data. Treatments are provided per routine clinical care and the registry collects outcome data without directing specific therapeutic interventions.
Who should consider this trial
Good fit: Adults (18+) diagnosed with a solid tumor who receive or plan to receive intra‑arterial therapy using RenovoCath and who are willing to provide informed consent and medical record access.
Not a fit: Patients who do not receive RenovoCath, have non‑solid (hematologic) cancers, are under 18, or cannot provide consent or medical records are unlikely to benefit from this registry's findings.
Why it matters
Potential benefit: If successful, this registry could clarify the real‑world safety profile and survival outcomes after RenovoCath‑facilitated intra‑arterial therapy, helping inform care decisions.
How similar studies have performed: Other intra‑arterial locoregional approaches (for example transarterial chemoembolization and hepatic arterial infusion) have shown benefit in selected solid tumors, but device‑specific evidence for RenovoCath is limited and being collected.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility Criteria: 1. 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 2. Patients willing to provide informed consent and HIPAA release for use of their relevant medical records
Where this trial is running
Coral Gables, Florida and 2 other locations
- Baptist Health South Florida — Coral Gables, Florida, United States (RECRUITING)
- University of Pennsylvania Medical Center — Pittsburgh, Pennsylvania, United States (RECRUITING)
- The University of Vermont Medical Center — Burlington, Vermont, United States (RECRUITING)
Study contacts
- Study coordinator: Leesa M Gentry
- Email: lgentry@renovorx.com
- Phone: 650-284-4433
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Solid Tumors, Intra-Arterial Catheter