Surefire Infusion System vs. Standard Microcatheter Use During Holmium-166 Radioembolization

NCT02208804 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-11-09

No results posted yet for this study

Summary

The objective of the SIM trial is to investigate whether using the Surefire Infusion System during holmium-166 radioembolization increases the posttreatment tumor to non-tumor activity concentration ratio, compared with using a standard end-hole microcatheter.

Conditions

  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Diseases
  • Digestive System Neoplasms

Interventions

DEVICE

Holmium-166-poly (L-lactic acid) microspheres

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Maurice AAJ van den Bosch, Prof. dr. · UMCU Utrecht, The Netherlands

  • Max A Viergever, Prof. dr. ir. · UMC Utrecht, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-11-30

Countries

  • Netherlands

Study Locations

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Entities

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 NCT02208804 on ClinicalTrials.gov