PumaRx Registry Trial (PumaRx)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Device: RenovoCath®

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Leesa M Gentry; Phone Number: 650-284-4433; Email: lgentry@renovorx.com
• Study Contact Backup: Name: Nicolette G Keller; Phone Number: 650-284-4433; Email: nkeller@renovorx.com

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33143
      • Recruiting
      • Baptist Health South Florida
      • Contact: Dr. Gandhi
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pennsylvania Medical Center
      • Contact: Dr. Novelli
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Recruiting
      • The University of Vermont Medical Center
      • Contact: Dr. O'Neill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients receiving Intra-Arterial treatment with RenovoCath	Device: RenovoCath®; Intra-arterial catheter delivery of chemotherapy agents for the collection of real-world data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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	From the time of the first treatment, until 30 days after the last treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Tumor Response Rate	Assess tumor response, via imaging, in the primary site of application	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	6 months from the date of the first IA treatment

Collaborators and Investigators

• Sponsor: RenovoRx

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): September 3, 2029
• Study Completion (Estimated): September 3, 2029

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Intra-Arterial Catheter
• Other Study ID Numbers: RR5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be shared with participating investigators only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No