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NCT04684862 · ClinicalTrials.gov registry record · NA
Infusion System for Hepatic Cancer
A NA study of Intrahepatic Cholangiocarcinoma and Colorectal Cancer Metastatic to Liver, sponsored by Ronald DeMatteo, M.D..
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT04684862 is a NA study of Intrahepatic Cholangiocarcinoma and Colorectal Cancer Metastatic to Liver that is active but no longer recruiting, run by Ronald DeMatteo, M.D.. The registered enrollment target is 100 participants, below the 130-participant average among 17 other Intrahepatic Cholangiocarcinoma trials with a reported enrollment target (23% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04684862, a NA study of Intrahepatic Cholangiocarcinoma and Colorectal Cancer Metastatic to Liver, is active but no longer recruiting, sponsored by Ronald DeMatteo, M.D..
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-site, open-label continued access study/treatment protocol under a treatment IDE. In addition to treating patients, the primary objective of this study is to assess the safety of using the Medtronic SynchroMed II programmable pump combined with the Intera tapered catheter for hepatic artery infusion (HAI) of a standard chemotherapy (FUDR) drug for adults with a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to the liver or intrahepatic cholangiocarcinoma. After successful implantation, the combined pump and catheter system will be evaluated using a nuclear scan in the postoperative period, which is standard procedure to confirm that the pump is functioning prior to HAI of FUDR. Monitoring for safety will include a record of residual pump volume when it is emptied (every 2-12 weeks depending on whether the pump is being used for chemotherapy infusion) to determine if the pump is still working and surveillance of routine cross-sectional imaging (usually every 2-6 months) for any sign of a pump or catheter problem. Patients will be monitored for the safety of the pump/catheter combination for up to 5 years or pump removal/study withdrawal.
Conditions Studied
Interventions
- DEVICE Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System)
Study Locations (1)
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-02-08 |
| Est. Completion | 2029-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04684862
The ClinicalTrials.gov registry entry for NCT04684862 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 130-participant average among 17 other Intrahepatic Cholangiocarcinoma trials with a reported enrollment target (23% lower). The listed sponsor is Ronald DeMatteo, M.D., which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Intrahepatic Cholangiocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System) is the first listed.
NCT04684862 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04684862 about?
NCT04684862 is a clinical study titled "Infusion System for Hepatic Cancer". This is a single-site, open-label continued access study/treatment protocol under a treatment IDE. In addition to treating patients, the primary objective of this study is to assess the safety of using the Medtronic SynchroMed II programmable pump combined with the Intera tapered catheter for hepati...
What is the current status of trial NCT04684862?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-02-08. Estimated completion is 2029-07.
What conditions does trial NCT04684862 study?
This clinical trial studies the following conditions: Intrahepatic Cholangiocarcinoma, Colorectal Cancer Metastatic to Liver.
What interventions are being tested in trial NCT04684862?
The interventions under investigation include: Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System) (DEVICE).
Who is sponsoring clinical trial NCT04684862?
This trial is sponsored by Ronald DeMatteo, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04684862 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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