PumaRx Registry Trial

NCT06805461 | Recruiting FDA Device

• 1 other identifier: RR5
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Solid Tumors

Keywords

Intra-Arterial Catheter

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Overall Survival

  24 months from date of first treatment with IA

• Tumor Response Rate

  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

  6 months from the date of the first IA treatment

Study Arms (1)

Patients receiving Intra-Arterial treatment with RenovoCath

Patients receiving Intra-Arterial treatment with RenovoCath

Device: RenovoCath®

Interventions

RenovoCath® DEVICE

Intra-arterial catheter delivery of chemotherapy agents for the collection of real-world data.

Patients receiving Intra-Arterial treatment with RenovoCath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• RenovoRx: lead

Study Sites (3)

Baptist Health South Florida

Coral Gables, Florida, 33143, United States

RECRUITING

University of Pennsylvania Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

The University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

Central Study Contacts

Leesa M Gentry

CONTACT

650-284-4433; lgentry@renovorx.com

Nicolette G Keller

CONTACT

650-284-4433; nkeller@renovorx.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: February 3, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 3, 2029
• Study Completion (Estimated): September 3, 2029
• Last Updated: March 30, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)