Solid TumorsPumaRxNCT06805461
PumaRx Registry Trial
An observational study of Solid Tumors, run by RenovoRx at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- RenovoCath®
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2025to 3 Sep 2029
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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:
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
The University of Vermont Medical Center
Burlington, Vermont, 05401
Dr. O'Neill
- Recruiting
Baptist Health South Florida
Coral Gables, Florida, 33143
Dr. Gandhi
- Recruiting
University of Pennsylvania Medical Center
Pittsburgh, Pennsylvania, 15213
Dr. Novelli
About this study
Official 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
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.
Read the 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.
- Conditions
- Solid Tumors
- Being tested
- RenovoCath®
- Keywords
- Intra-Arterial Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenovoCath®Device
Intra-arterial catheter delivery of chemotherapy agents for the collection of real-world data.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving Intra-Arterial treatment with RenovoCath | Patients receiving Intra-Arterial treatment with RenovoCath Receives: Device: RenovoCath® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From the time of the first treatment, until 30 days after the last treatment
Secondary outcomes (3)
Overall Survival
Evaluate overall survival (OS) in patients diagnosed with solid tumors who undergo localized IA delivery of therapeutic agents via the RenovoCath®
Measured: 24 months from date of first treatment with IA
Tumor Response Rate
Assess tumor response, via imaging, in the primary site of application
Measured: 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
Measured: 6 months from the date of the first IA treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Aug 2025
- Primary completion3 Sep 2029 (estimated)
- Study completion3 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- RenovoRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805461
- Sponsor's protocol ID
- RR5
- Acronym
- PumaRx
- Status last verified
- Oct 2025
- First submitted
- 10 Jan 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will be shared with participating investigators only.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06805461
- Acronym / sponsor ID
- PumaRx / RR5
- Conditions
- Solid Tumors
- Keywords
- Intra-Arterial Catheter
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- RenovoRxIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 3 Sep 2029 (estimated)
- Study completion
- 3 Sep 2029 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving Intra-Arterial treatment with RenovoCath | – | Device: RenovoCath®Patients receiving Intra-Arterial treatment with RenovoCath |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RenovoCath®Intra-arterial catheter delivery of chemotherapy agents for the collection of real-world data. | Device | Patients receiving Intra-Arterial treatment with RenovoCath |
Primary outcome
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.
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
3 secondary outcomes
Overall Survival
Time frame: 24 months from date of first treatment with IA
Tumor Response Rate
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
Time frame: 6 months from the date of the first IA treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No. IPD will be shared with participating investigators only.
Related trials for Solid Tumors
Active, not recruitingPhase 2
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Active, not recruitingPhase 1
A Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001)
Advanced Solid Tumors, Solid Tumor
RecruitingPhase 2
Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors
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Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumors, run by RenovoRx at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leesa M Gentry (650-284-4433, lgentry@renovorx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.