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

October 18, 2021 updated by: RenovoRx

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

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.

Study Overview

Status

Completed

Conditions

Pancreatic Neoplasms

Intervention / Treatment

Device: RenovoCath™ R120 Catheter

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - San Jose, California, United States, 95154
    - Good Samaritan Hospital
- Florida
  - Port Charlotte, Florida, United States, 33952
    - Fawcett Memorial Hospital
  - Tampa, Florida, United States, 33613
    - Florida Hospital
- New York
  - Bronx, New York, United States, 10461
    - Montefiore Hospital
- North Carolina
  - Greenville, North Carolina, United States, 27834
    - East Carolina University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with unresectable or borderline resectable pancreatic cancer.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival Time Frame: 2 Years	Duration of survival in patients diagnosed with pancreatic cancer who undergo intra-arterial delivery of chemotherapeutic agents to the pancreas	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor response Time Frame: 6 months	Time to tumor response in the primary site of application as assessed by imaging.	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenovoRx

Investigators

Study Director: Ramtin Agah, MD, Chief Medical Officer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

February 26, 2021

Study Completion (Actual)

February 26, 2021

Study Registration Dates

First Submitted

October 27, 2015

First Submitted That Met QC Criteria