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Hepatic Artery Infusion (HAI) Program at Duke University

NCT04511793 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-07-19

No results posted yet for this study

Summary

The Duke HAI program was implemented in November 2018 and treated 30 patients in its first 17 months using the Medtronic Synchromed II device (only commercially available device suitable for HAI for cancer patients). The Duke HAI program has demonstrated safety of HAI with an overall complication rate was 19%, similar to prior published data, with all but one complication (extrahepatic perfusion) salvaged. The Investigator has also demonstrated feasibility and efficacy of a new HAI program, with 95% of patients initiating therapy with promising hepatic response and disease control rates. This protocol will enable the team to continue this program. All eligible patients will receive the synchromed II pump with a Codman catheter and chemotherapy including FUDR, dexamethasone and heparin. Systemic chemotherapy will be given per standard of care.

Conditions

Interventions

DEVICE

Medtronic Synchromed II pump

The pump will be placed during surgery and the pump will be filled with a combination of floxuridine (FUDR), dexamethasone, heparin, and saline.

Sponsors & Collaborators

  • Michael Lidsky, M.D.

    lead OTHER

Principal Investigators

  • Michael Lidsky, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-11
Primary Completion
2022-06-30
Completion
2022-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04511793 on ClinicalTrials.gov