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

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591082
• Other study ID #: RR2
• Status: Completed
• Start date: December 2015
• Est. completion date: February 26, 2021

Study information

• Verified date: October 2021
• Source: RenovoRx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 26, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Montefiore Hospital	Bronx	New York
United States	East Carolina University	Greenville	North Carolina
United States	Fawcett Memorial Hospital	Port Charlotte	Florida
United States	Good Samaritan Hospital	San Jose	California
United States	Florida Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
RenovoRx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Duration of survival in patients diagnosed with pancreatic cancer who undergo intra-arterial delivery of chemotherapeutic agents to the pancreas	2 Years
Secondary	Tumor response	Time to tumor response in the primary site of application as assessed by imaging.	6 months