MedTrace Logo

Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.

NCT02732769 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2018-10-03

No results posted yet for this study

Summary

the Mask fixation isn't a new solution for the immobilization of the patient's head and has been used in current practice for long years.

This trial is attempting to compare these two technical possibilities of head fixation by mask or by stereotaxic frame. The primary goal is to evaluate the comfort for the patient and specifically for each step of the procedure. It will also evaluate other parameters such as the effectiveness of these two strategies and tolerance.The expected benefit is an improvement of the comfort for the patients.

Conditions

Interventions

DEVICE

GammaKnifePerfexion®

neurosurgery

DEVICE

GammaKnifeIcon®

neurosurgery

DEVICE

Efficast®

Thermoformed mask

DEVICE

MRI

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • DESALBRES · ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-07-27
Completion
2018-03-21

Countries

  • France

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 NCT02732769 on ClinicalTrials.gov