Multicenter Trial of Magnetic Mini-Mover for Pectus Excavatum (3MP)
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).
Device: Magnetic Mini-Mover Procedure (Magnimplant)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 3 Multicenter Study of Magnetic Mini-Mover for Pectus Excavatum|
- Amount of time necessary to correct pectus deformity to a PSI < 3.25 [ Time Frame: 18-24 months after implant ] [ Designated as safety issue: No ]The rate of correction and final position of the sternum will be measured using the Pectus Severity Index. The mean value for pectus patients is approximately 4.98 and the normal chest is 2.56. Correction is defined as P.I. < 3.25.
- Safety [ Time Frame: During treatment, 18-24 months ] [ Designated as safety issue: Yes ]All adverse reactions will be recorded and reported to the IRB and the FDA, including complications from implantation of the device,complications from application of the external device over time (e.g., changes in skin; infection; changes in cardiac electrical function).
- Comfort [ Time Frame: During treatment, 18-24 months ] [ Designated as safety issue: No ]Comfort of the external brace directly affects compliance (i.e., bracewear) and compliance will be measured throughout treatment. In addition, the satisfaction of the patient and family will be measured using a standard Quality of Life (QOL) questionnaire administered 1 month after implanting the device and 1 month after removing the device.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment Arm
This is a non-randomized study in which otherwise healthy patients, ages 8-14, with severe pectus excavatum (PSI > 3.5) will undergo outpatient surgery to both place and later explant the Magnimplant device, and will be fitted for an orthotic brace, which houses the external magnet and records brace-wear compliance. They will undergo 3MP treatment for 18-24 months, enough to attempt to improve their PSI (< 3.25).
Device: Magnetic Mini-Mover Procedure (Magnimplant)
This is a non-randomized study in which otherwise healthy patients, ages 8-14, with severe pectus excavatum (PSI > 3.5) will undergo outpatient surgery to both place and later explant the Magnimplant device. Patients will be required to wear a custom-fitted orthotic brace, which houses the external magnet and records brace-wear compliance. They will undergo 3MP 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.
Other Name: IDE G090006
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 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.
|United States, California|
|Shriners Hospitals for Children|
|Sacramento, California, United States, 95817|
|UCSF-Benioff Children's Hospital|
|San Francisco, California, United States, 94143|
|United States, Missouri|
|Children's Mercy Hospitals|
|Kansas City, Missouri, United States, 64108|
|Study Director:||Michael R Harrison, MD||University of California, San Francisco|
|Principal Investigator:||Shinjiro Hirose, MD||University of California, San Francisco|