Multicenter Trial of Magnetic Mini-Mover for Pectus Excavatum
Completed · Not applicable
Conditions studied: Pectus Excavatum
In brief
This study is a Phase 3, multicenter, non-randomized study to evaluate the safety and efficacy of the next-generation outpatient Magnetic Mini-Mover Procedure (3MP) in 15 patients aged 8-14 years for the correction of pectus excavatum ('sunken chest'). 3MP for pectus excavatum uses a magnetically coupled implant to pull the sternum forward and gradually remodel the deformed costal cartilage. The Funding Source for this trial is the FDA Office of Orphan Products Development (Grant #R01 FD003341).
Key facts
- Study ID
- NCT01327274
- Run by
- Michael Harrison
- People needed
- 15
- Starts
- 2011-12-01
- Expected to finish
- 2018-05-01
- Last updated by the study team
- 2018-11-08
Who can join
Age: 8 and older, up to 14. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Otherwise healthy male or female with pectus excavatum deformity
- Between 8 and 14 years of age (inclusive)
- Pectus Severity Index > 3.5 (normal 2.56). NOTE: A pectus severity index of 3.5 or greater qualifies as a moderate-to-severe deformity, and justifies operative intervention
- Ability to read, speak and understand English
- Onset of rapid growth of puberty documented by hand/wrist x-ray in early to mid-puberty (defined as bone age in females of 7-13 years, and males of 9-14 years)
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
- Refusal to undergo monthly chest x-rays
- Inability or refusal to return to UCSF for biweekly follow-up visits for the first month after surgery, and monthly thereafter until explant.
- Inability to obtain pre-approval (authorization) from the patient's insurance carrier
Where it is running
- Shriners Hospitals for Children — Sacramento, California, United States
- UCSF-Benioff Children's Hospital — San Francisco, California, United States
- Children's Mercy Hospitals — Kansas City, Missouri, United States
Full record on ClinicalTrials.gov
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