Intra-Arterial Treatment of Pancreatic Cancer Using the RenovoCath™ RC120 Catheter

Study Overview
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Brief Summary
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This is an observational study to assess patient survival and clinical outcomes after the RenovoCath™ RC120 catheter is used to deliver chemotherapeutic agents to pancreatic tumors.

Detailed Description
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This is an observational, registry study to assess patient survival and clinical outcomes of the RenovoCath™ RC120 catheter when used to deliver chemotherapeutic agents to pancreatic tumors. Blood samples will be drawn in a subset of patients to assess the systemic concentration of the chemotherapeutic agent. The RenovoCath™ RC120 Catheter is an endovascular multi-lumen, two-handled catheter designed to isolate variable segments of arteries supplying the target organ using two slideable, compliant balloons. Upon inflation of the proximal occlusion balloon and the distal occlusion balloon, the catheter may isolate the selected site to specifically deliver radiopaque and therapeutic agents including, but not limited to chemotherapeutic drugs.

Official Title
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A Multi-Center, Post-Marketing, Prospective, Observational Study Following Treatment With Intra-Arterial Delivery of Chemotherapeutic Agents Using the RenovoCath™ RC120 Catheter

Conditions
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Pancreatic Neoplasms

Intervention / Treatment
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* Device: RenovoCath™ R120 Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age Diagnosed with unresectable or borderline resectable pancreatic adenocarcinoma confirmed by histology or cytology Without current myelotoxicity and with sufficient health status to undergo a catheterization procedure Willing to provide informed consent and comply with the required follow-up. Exclusion Criteria: Have received prior chemotherapy and/or radiation therapy within 14 days prior to the first intra-arterial treatment. Currently participating in another active drug or device study or registry protocol that would interfere with this study. Vulnerable populations: prisoners, pregnant or breastfeeding females.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: RenovoCath™ R120 Catheter|The RenovoCath™ RC120 Catheter will be used to isolate segments of arteries supplying blood to the pancreas. The two balloons on the catheter will be positioned and inflated to temporarily stop blood flow while medication is infused through the catheter between the balloons.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Duration of survival in patients diagnosed with pancreatic cancer who undergo intra-arterial delivery of chemotherapeutic agents to the pancreas | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response | Time to tumor response in the primary site of application as assessed by imaging. | 6 months |