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This is an observational study to assess patient survival and clinical outcomes after the RenovoCathâ„¢ 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 RenovoCathâ„¢ 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 RenovoCathâ„¢ 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RenovoCathâ„¢ R120 Catheter | Device | The RenovoCathâ„¢ 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response | Time to tumor response in the primary site of application as assessed by imaging. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with unresectable or borderline resectable pancreatic cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Ramtin Agah, MD | Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Samaritan Hospital | San Jose | California | 95154 | United States | ||
| Fawcett Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39049803 | Derived | Hatoum H, Rosemurgy A 2nd, Bastidas JA, Zervos E, Muscarella P 2nd, Edil BH, Cynamon J, Johnson DT, Thomas C, Swinson BM, Nordgren A, Vitulli P, Nutting C, Gipson M, Tsobanoudis A, Agah R. Treatment of locally advanced pancreatic cancer using localized trans-arterial micro perfusion of gemcitabine: combined analysis of RR1 and RR2. Oncologist. 2024 Aug 5;29(8):690-698. doi: 10.1093/oncolo/oyae178. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 4, 2022 | |
| Reset | May 20, 2022 | |
| Release | May 23, 2022 | |
| Reset | Feb 22, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 4, 2022 | May 20, 2022 | |||
| May 23, 2022 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Port Charlotte |
| Florida |
| 33952 |
| United States |
| Florida Hospital | Tampa | Florida | 33613 | United States |
| Montefiore Hospital | The Bronx | New York | 10461 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Feb 22, 2023 |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |