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Pilot Study of an Implantable Microdevice for Colorectal Liver Metastasis

This study is looking at a new way to understand how well cancer drugs work in liver tumors. It's testing a small implantable device that will be placed into liver tumors caused by colorectal cancer. The device will be put in 3-5 days before your planned surgery to remove the liver tumor, and then removed along with the tumor. The study aims to see if placing and removing this device causes any problems or complications. You might be eligible if you have colorectal cancer that has spread to your liver, your liver tumor is at least 2 cm, and you are already scheduled for surgery to remove part of your liver. The study is currently unclear on its recruitment status and plans to enroll 10 participants. The main goal is to check for any adverse events (side effects) related to the device placement and removal over 12 months.

Study design
This is an interventional study with a planned enrollment of 10 participants. It is a safety study focused on the placement and retrieval of a microdevice.
What's involved
If you join, a small device will be placed into your liver tumor 3-5 days before your scheduled surgery. The device will then be removed during your surgery.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for adverse events related to the device for 12 months after placement and retrieval.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07193862

Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Northwell Health
~10 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Doxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs) associated with Microdevice placement and retrieval
Measured over 12 months

Conditions

Colorectal Cancer Metastatic

Explore related trials

Colorectal Carcinoma

Where it's being run

2 sites across 1 states
New York2

Who to contact

Micaela Wigfall Maxwell
[email protected]
833-223-4732
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically confirmed colorectal cancer with suspicion of liver metastasis on imaging Liver tumor ≥2 cm on preoperative imaging via computed tomography (CT) or magnetic resonance imaging (MRI) Planned hepatectomy as part of standardized treatment plan, irrespective of study enrollment ≥18 years of age
Leukocytes ≥3,000/mcL
Absolute neutrophil count ≥1500/mcL
Platelets ≥ 100,000/mcL
PT≤ 14, PTT≤ 38, INR ≤ 1.
Creatinine within normal institutional limits OR clearance ≥60mL/min/1.73m2 Feasibility of microdevice implantation based on clinical history as well as extent and anatomical location of the CLM tumor as evaluated by the operating surgical oncologist and interventional radiologist on baseline imaging The effects of the microdevice on a developing human fetus are unknown. For this reason and because the therapeutic agents used in this trial are known to be teratogenic, women of childbearing age must agree to have a negative serum pregnancy test within 48 hours of their operation Ability to understand and willingness to sign informed consent for both the surgical resection and the proposed research study prior to any procedures

What this trial measures

  • Incidence of adverse events (AEs) associated with Microdevice placement and retrieval12 months

    To evaluate the safety of microdevice placement and retrieval based on assessment of adverse events. AEs will be defined using Common Terminology Criteria for AEs (CTCAE) v5.0 Any device resulting in either of the following will be considered a failure from a safety standpoint: any listed SAE two or more grade 3-4 AEs directly associated with the device or its placement Significant delay in the standard hepatic resection of more than 14 days due to device-related complications Safety will be evaluated on a per-patient level, where an event is defined as any "failure" observed among all devices. This is a phase 1 pilot safety trial that must only demonstrate the ability to perform this procedure without undue risk