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

RenovoRx25 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pancreatic Neoplasms

Interventions

RenovoCath™ R120 CatheterDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Good Samaritan Hospital

San Jose, California, United States

Fawcett Memorial Hospital

Port Charlotte, Florida, United States

Florida Hospital

Tampa, Florida, United States

Montefiore Hospital

The Bronx, New York, United States

Outcomes

Primary Outcomes

Survival

Duration of survival in patients diagnosed with pancreatic cancer who undergo intra-arterial delivery of chemotherapeutic agents to the pancreas

Time frame: 2 Years

Secondary Outcomes

Tumor response

Time to tumor response in the primary site of application as assessed by imaging.

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.