Pancreatic Neoplasms
Conditions
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.
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.
Interventions
DEVICERenovoCath™ 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.
Sponsors
RenovoRx
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 2 Years | Duration of survival in patients diagnosed with pancreatic cancer who undergo intra-arterial delivery of chemotherapeutic agents to the pancreas |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response | 6 months | Time to tumor response in the primary site of application as assessed by imaging. |
Countries
United States
Outcome results
None listed