- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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San Jose, California, United States, 95154
- Good Samaritan Hospital
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Florida
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Port Charlotte, Florida, United States, 33952
- Fawcett Memorial Hospital
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Tampa, Florida, United States, 33613
- Florida Hospital
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New York
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Bronx, New York, United States, 10461
- Montefiore Hospital
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North Carolina
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Greenville, North Carolina, United States, 27834
- East Carolina University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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2 Years
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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
Sponsor
Investigators
- Study Director: Ramtin Agah, MD, Chief Medical Officer
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RR2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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