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NCT Number: NCT06805461

PumaRx Registry Trial

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baptist Health South Florida, Coral Gables, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria:

  • 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
  • Patients willing to provide informed consent and HIPAA release for use of their relevant medical records

Treatment and study plan

RenovoCath®

Device

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

Primary outcomes

  1. Safety of RenovoCath® as assessed by the 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

    Number of participants experiencing adverse events related to the chemotherapy agents administered using RenovoCath.

  2. Performance of RenovoCath® as assessed by the number of participants experiencing adverse events related to the inter-arterial drug delivery procedure.

    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

Secondary outcomes

  1. Overall Survival

    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®

  2. Tumor Response Rate

    Time frame: 24 months from date of first treatment with IA

    Assess tumor response, via imaging, in the primary site of application

  3. Number of participants who are downstaged and have their tumor resected after IA treatment with RenovoCth

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Leesa M Gentry

CONTACT

[email protected]

650-284-4433

Nicolette G Keller

CONTACT

[email protected]

650-284-4433

Sponsors and collaborators

Lead sponsor

RenovoRx

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Feb 3, 2025
Registry last updated
Mar 30, 2026

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.

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