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Non-invasive Focal Therapy for Osteoid Osteoma

NCT02302651 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-11-27

No results posted yet for this study

Summary

Non-invasive treatment of Osteoid osteoma using MRI guided high-intensity focused ultrasound. This study is designed as an intention-to-treat using a totally non-invasive approach for pain reduction, quality of life improvement and long-term bone restoration. Procedure is performed in a single session using limited amount of acoustic energy to target the osteoid nidus. Treatment will be performed under anesthesia (peripheral or general according to age and lesion position).

Conditions

  • Osteoma, Osteoid

Interventions

DEVICE

MR guided High Intensity focused ultrasound

High Intensity Focused Ultrasound is a totally non-invasive procedure that can destroy tumors transcutaneously; safety and efficacy profile are dramatically increased by the MRI guidance

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Alessandro napoli, MD, PhD · Sapienza University of Rome, Policlinico Umberto I Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2015-06-30
Completion
2015-12-31

Countries

  • Italy

Study Locations

More Related Trials

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 NCT02302651 on ClinicalTrials.gov