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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: Active NA study of Intrahepatic Cholangiocarcinoma and Colorectal Cancer Metastatic to Liver, sponsored by Ronald DeMatteo, M.D..
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
TAEs are defined as AEs deemed related to the combination of the devices (i.e., the connection between the Medtronic pump and Intera Catheter).
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 |
What the registry record for NCT04684862 still lists
NCT04684862 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 130-participant average among 17 other Intrahepatic Cholangiocarcinoma trials with a reported enrollment target (23% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04684862's enrollment target sits among peer trials
100 7th of 17 higher than 11 of 17 other Intrahepatic Cholangiocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Intrahepatic Cholangiocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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