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Efficacy of HIFU-AR on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy

NCT02728167 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-08-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether HIFU-assisted liver resection (HIFU-AR) results in reduced blood loss compared to standard liver resection in patients with LM.This is a prospective, monocentric, randomized (1:1 ratio), comparative, open-label Phase II study.

Conditions

  • Liver Metastasis

Interventions

DEVICE

Pre-coagulation of the liver parenchyma with HIFU

6 to 10 (or more if necessary) side-to-side 40-seconde HIFU treatments

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Michel RIVOIRE, MD, PhD · Centre Leon Bérard

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-07-31
Completion
2018-08-31

Countries

  • France

Study Locations

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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 NCT02728167 on ClinicalTrials.gov