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

Completed

• Conditions: Pancreatic Neoplasms

• Registration Number: NCT02591082
• Lead Sponsor: RenovoRx

Brief 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.

Study Timeline

• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-29
• Study Start: 2015-12
• Primary Completion: 2021-02-26
• Study Completion: 2021-02-26
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	2 Years	Duration of survival in patients diagnosed with pancreatic cancer who undergo intra-arterial delivery of chemotherapeutic agents to the pancreas

Secondary Outcome Measures

Name	Time	Method
Tumor response	6 months	Time to tumor response in the primary site of application as assessed by imaging.

Trial Locations

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; 🇺🇸 Bronx, New York, United States

East Carolina University; 🇺🇸 Greenville, North Carolina, United States