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BioPearl™ Microspheres Loaded With Doxorubicin: Prospective, Single Arm, Multi-centre Post-market Follow-up Study.

NCT04231929 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-03-28

No results posted yet for this study

Summary

The primary objective of the study is to confirm safety and efficacy of BioPearl™ microspheres loaded with doxorubicin in the treatment of patients with unresectable hepatocellular carcinoma (HCC).

Conditions

Interventions

DEVICE

Chemoembolization

First, an angiography of the celiac trunk, superior mesenteric artery and hepatic artery will be obtained by using a peripheral arterial approach. Arterial embolization will be performed through catheterization of intrahepatic arteries, as selectively as possible (tumor feeders, subsegmental, segmental). The size of the microcatheter must be consistent with the size of BioPearl™ microspheres used. Microspheres of 200 µm will be be used. They will be loaded with the appropriate dose of doxorubicin injectable solution, mixed with the contrast media and distributed according to the location of the HCC lesions. The endpoint of the procedure will be achieved end when stasis of the feeders is achieved.

Sponsors & Collaborators

  • Terumo Europe N.V.

    lead INDUSTRY

Principal Investigators

  • Gontran Verset, MD · CUB Hôpital Erasme

  • Geert Maleux, MD · UZ Leuven

  • Luc Defreyne, MD · UZ Gent

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-31
Primary Completion
2021-03-31
Completion
2023-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

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 NCT04231929 on ClinicalTrials.gov