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.
Brief Title
Intra-Arterial Treatment of Pancreatic Cancer Using the RenovoCath™ RC120 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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Pancreatic Neoplasms
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02591082
Org Class
Industry
Org Full Name
RenovoRx
Org Study Id
RR2
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Multi-Center, Post-Marketing, Prospective, Observational Study Following Treatment With Intra-Arterial Delivery of Chemotherapeutic Agents Using the RenovoCath™ RC120 Catheter
Primary Outcomes
Outcome Description
Duration of survival in patients diagnosed with pancreatic cancer who undergo intra-arterial delivery of chemotherapeutic agents to the pancreas
Outcome Measure
Survival
Outcome Time Frame
2 Years
Secondary Outcomes
Outcome Description
Time to tumor response in the primary site of application as assessed by imaging.
Outcome Time Frame
6 months
Outcome Measure
Tumor response
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Patients diagnosed with unresectable or borderline resectable pancreatic cancer.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Peter Muscarella
Investigator Email
pmuscare@montefiore.org
Investigator Phone