NCT02591082

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: RenovoRx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2021-02-26
• Completion: 2021-02-26
• First posted: 2015-10-29
• Last updated: 2021-10-20

Locations

5 sites across 1 country: United States