Magnetic Mini-Mover Procedure to Treat Pectus Excavatum

Completed · Phase 1/Phase 2

Conditions studied: Pectus Excavatum

In brief

This is a medical research study. The study investigators have developed a method to gradually repair pectus excavatum (sunken chest) deformity by placing a magnet on the sternum (breastbone) and then applying an external magnetic force that will pull the sternum outward gradually. Potential candidates for this study are children and adolescents with a previously diagnosed congenital pectus excavatum (sunken chest) deformity who are otherwise healthy and are seeking corrective surgery for their condition. They will be residents of the U.S. and between the ages of 8 and 14 years of age. Potential candidates and their families will have already been counseled about this condition and about the standard way to repair this deformity. The purpose of this study is to test what effects, good and/or bad, placing an external/internal magnetic device has on correcting pectus excavatum deformity in children, and the safety of using such a device for treatment.

Key facts

Study ID

NCT00466206

Run by

University of California, San Francisco

People needed

10

Starts

2007-04-01

Expected to finish

2011-04-01

Last updated by the study team

2016-01-01

Who can join

Age: 8 and older, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Resident of the U.S.;
• Otherwise healthy male or female with pectus excavatum deformity;
• Between 8 and 14 years of age;
• Pectus Severity Index > 3.5 (normal 2.56); and
• Ability to read and speak English.

You may not qualify if…

• Other congenital anomalies (including significant skeletal anomalies such as scoliosis, bony fusion involving the cervical vertebrae) not directly related to pectus excavatum;
• Bleeding disorders;
• Heart disease (including arrhythmia);
• Persons with active implantable medical devices (AIMD) such as pacemakers;
• Persons with a relative(s) or close family friend(s) living within their households and having a pacemaker;
• Persons with arteriovenous malformations;
• Chest deformity more complicated than pectus excavatum (e.g.. Poland syndrome);
• Persons for whom a foreign body implant would pose a risk (e.g., immunodeficiency);
• Persons at increased risk for general anesthesia (e.g., history of malignant hyperthermia);
• Respiratory conditions that have required steroid treatment (e.g., prednisone)in the last 3 years;
• Pregnancy;
• Inability to understand or follow instructions;
• Refusal to wear the external brace;
• Inability to obtain pre-approval (authorization) from the patient's insurance carrier; and
• Inability or refusal to return to UCSF for weekly follow-up visits for the first month after surgery.

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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