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Device

Combined Infusion System for Hepatic Cancer

N/A
Recruiting
Research Sponsored by Ronald DeMatteo, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be greater than or equal to 18 years of age
At the time of pump placement, patients will either have unresectable, chemotherapy-responsive disease or they will be undergoing resection with planned postoperative HAI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from surgery up to 60 months post-surgery or study withdrawal
Awards & highlights

Study Summary

This trial is for adults with colorectal cancer metastatic to the liver or intrahepatic cholangiocarcinoma who will receive the Medtronic SynchroMed II programmable pump combined with the Intera tapered catheter for hepatic artery infusion (HAI) of a standard chemotherapy (FUDR). The primary objective is to assess the safety of using this pump/catheter combination.

Who is the study for?
This trial is for adults with colorectal cancer that has spread to the liver or intrahepatic cholangiocarcinoma. Candidates should be suitable for pump chemotherapy, as determined by medical and surgical oncologists, and must consent to participate. They may have inoperable disease responding to chemotherapy or plan postoperative hepatic artery infusion.Check my eligibility
What is being tested?
The study tests a Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter system for delivering chemotherapy directly into the liver. The safety of this method using FUDR (a standard chemo drug) will be monitored through nuclear scans and routine imaging over up to five years.See study design
What are the potential side effects?
While specific side effects are not listed, potential risks include complications from device implantation, reactions to the chemotherapy drug FUDR such as nausea or decreased blood counts, and issues related to the pump/catheter function which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am getting a pump for my inoperable cancer that responds to chemo, or I am having surgery with planned chemo via a pump afterwards.
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My cancer started in the colon or rectum and has spread to the liver, or I have cancer that began in the liver's bile ducts.
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Both my cancer doctors agree I should get chemotherapy through a pump.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from surgery up to 60 months post-surgery or study withdrawal
This trial's timeline: 3 weeks for screening, Varies for treatment, and from surgery up to 60 months post-surgery or study withdrawal for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Targeted Adverse Events (TAEs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hepatic Artery Infusion (HAI) TherapyExperimental Treatment1 Intervention
Eligible patients will be implanted with a device that combines components of two commercially available drug delivery pumps to administer regional chemotherapy (FUDR) to the liver. Specifically, a Medtronic pump is being used with an Intera tapered catheter, instead of the Medtronic catheter.

Find a Location

Who is running the clinical trial?

Ronald DeMatteo, M.D.Lead Sponsor

Media Library

Medtronic SynchroMed II programmable pump (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04684862 — N/A
Colorectal Cancer Research Study Groups: Hepatic Artery Infusion (HAI) Therapy
Colorectal Cancer Clinical Trial 2023: Medtronic SynchroMed II programmable pump Highlights & Side Effects. Trial Name: NCT04684862 — N/A
Medtronic SynchroMed II programmable pump (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04684862 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants currently engaged in this clinical trial?

"Affirmative. Clinicaltrials.gov states that this experiment, which was first published on the 8th of February 2021, is presently recruiting volunteers. Approximately 100 subjects must be recruited from 1 specific site."

Answered by AI

Are individuals currently being accepted to participate in this clinical research?

"Indeed, the clinicaltrials.gov page denotes this medical experiment is presently in recruitment phase. It was first launched on February 8th 2021 and most recently updated on July 14th 2022. An even 100 patients are sought from a single location for participation."

Answered by AI
~63 spots leftby Jul 2029