PumaRx Registry Trial
ConditionSolid Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRenovoRx
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
RenovoCath®
DeviceIntra-arterial catheter delivery of chemotherapy agents for the collection of real-world data.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Patients receiving Intra-Arterial treatment with RenovoCath1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From the time of the first treatment, until 30 days after the last treatment2
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
Time frame
From the time of the first treatment, until 30 days after the last treatmentSecondary outcomes
1
Overall Survival
Evaluate overall survival (OS) in patients diagnosed with solid tumors who undergo localized IA delivery of therapeutic agents via the RenovoCath®
Time frame
24 months from date of first treatment with IA2
Tumor Response Rate
Assess tumor response, via imaging, in the primary site of application
Time frame
24 months from date of first treatment with IA3
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
Time frame
6 months from the date of the first IA treatment Source ClinicalTrials.gov