Status:
COMPLETED
Magnetic Mini-Mover Procedure to Treat Pectus Excavatum
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
FDA Office of Orphan Products Development
Conditions:
Pectus Excavatum
Eligibility:
All Genders
8-14 years
Phase:
PHASE1
PHASE2
Brief Summary
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 the...
Detailed Description
Pectus excavatum is the most common congenital chest wall abnormality in children. Surgical correction requires a big operation under general anesthesia which forces the sternum forward and holds it i...
Eligibility Criteria
Inclusion
- Residents of the United States with previously diagnosed pectus excavatum who are referred to the UCSF Pediatric Surgery Service for evaluation and treatment will be considered for participation in this study. Only patients with moderate to severe pectus excavatum who meet all the inclusion criteria will participate. The patient and family will be fully counseled and consented about the risks and benefits of participation in the study, and will be asked to sign an informed consent reviewed and approved by the UCSF Committee on Human Research.
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00466206
Start Date
April 1 2007
End Date
April 1 2011
Last Update
January 1 2016
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143-0570