Intra-Arterial Treatment Of Pancreatic Cancer Using The RenovoCath™ RC120 Catheter

Study Overview

Intra-Arterial Treatment of Pancreatic Cancer 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.

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.

Pancreatic Neoplasms

DEVICE: RenovoCath™ R120 Catheter

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-10-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-10-18
First Submitted that Met QC Criteria 2015-10-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-10-20
First Posted (ACTUAL) 2015-10-29	Results First Posted N/A	Last Verified 2021-10

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

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

Investigators

STUDY_DIRECTOR: Ramtin Agah, MD, Chief Medical Officer

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record