Multicenter Trial of Magnetic Mini-Mover for Pectus Excavatum
Condition: Pectus Excavatum
MeSH terms: Funnel Chest
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      Pectus excavatum is the most common congenital chest wall abnormality in children. The
      investigators have developed a novel method of achieving gradual deformation/reformation of
      chest wall cartilage. A magnetic force field is used to apply controlled, sustained force to
      promote biologic reformation of structural cartilage. A magnet is implanted on the sternum
      and secured through a 2-inch subxiphoid incision as a one-hour outpatient procedure. The
      magnet (and sternum) is pulled outward by another magnet suspended in a novel, low-profile,
      lightweight device previously molded to the patient's anterior chest wall. The low-profile,
      non-obtrusive anterior chest wall prosthesis is held in place by the force field between the
      two magnets.

      In the single-center, FDA-funded trial (IDE G050196), the investigators tested proof of
      concept, safety and probable benefit of this procedure in 10. In this Phase III multicenter
      trial, the investigators will further test the safety and efficacy of the procedure in 15
      otherwise healthy patients with moderate-to-severe PE, ages 8 to 14. The investigators will
      be using the next generation Magnetic Mini-Mover Magnimplant device (IDE G090006), a design
      the investigators believe is much improved in terms of safety and ease of
      implantation/explantation. Implantation of the Magnimplant will be accomplished in an
      outpatient procedure. The investigators will document the rate of correction by comparing
      chest X-ray measurement of the Pectus Severity Index prior to implantation, to that measured
      after the magnet is removed. Treatment will last 18-24 months, depending on correction and
      when the patient has completed his or her pubertal growth spurt, as documented by hand x-ray.
      Explant of the device will be accomplished in an outpatient procedure. The investigators will
      document safety with an EKG prior to implantation, one month post-implantation, and finally
      after the magnet is removed. The investigators will document efficacy by comparing pre- and
      post-treatment PSI, as well as by evaluating patient satisfaction with a post-procedure
      Quality of Life-type survey. Long-term follow-up will occur at 6, 12, 18, and 24 months after
      explantation.
    

Intervention name(s): Magnetic Mini-Mover Procedure (Magnimplant)
Intervention type(s): Device
Intervention description(s): This is a non-randomized study in which otherwise healthy patients, ages 8-14, with severe pectus excavatum (PSI > 3.5) will undergo the Magnetic Mini-Mover procedure outpatient surgery. The Magnimplant or Magnetic Mini-Mover device implant will surgically implanted on the sternum. Patients will be required to wear a custom-fitted orthotic brace, which houses the external magnet and records brace-wear compliance. They will undergo brace treatment for 18-24 months, enough to attempt to improve their PSI (< 3.25). Patients will be seen in clinic at least monthly until treatment is complete and the magnimplant device will be explanted from their sternum.
Other intervention name(s): IDE G090006
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pectus excavatum; Chest wall deformity; Magnetic Mini-Mover Procedure; Pectus Severity Index; pediatric medical device; magnetic alteration; sunken chest