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

RenovoRx

Status: Completed

Conditions: Pancreatic Neoplasms

Treatments: Device: RenovoCath™ R120 Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT02591082

RR2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.