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ACTIVE NOT RECRUITING NA

Infusion System for Hepatic Cancer

NCT04684862 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 100 participants
Start Date 2021-02-08
Est. Completion 2029-07
Phase NA

Sponsor

Ronald DeMatteo, M.D.

1 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ronald DeMatteo, M.D., which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04684862 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

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. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial