The Magnetic Mini-Mover Trial Study is now open closed for enrollment
The Magnetic Mini-Mover Procedure is a medical research study to test what effect placing an external and internal magnetic device has on correcting pectus excavatum deformity in children, and the safety of using such a device for treatment. This research study was already undergone a pilot study in 10 patients for safety and probable efficacy. The results of the study will be posted in June 2011. The study is now entering a multicenter clinical trial to continue to look at efficacy and use in other institutions.
How do I know if my child or I qualify for this study?
You or your child may qualify for this study if:
- You are a healthy boy or girl 8-14 years of age with significant pectus excavatum [Pectus Severity Index > 3.5 (normal is 2.56)] and no other health problems.
- You are in early or mid-puberty based on bone age.
- You are seeking corrective surgery for the pectus deformity.
- You are able to read, speak, and understand English
How long will my child or I be in the study?
Participation in the main part of the study is expected to take 18 to 24 months, depending on how long it takes to correct the pectus excavatum deformity. This means the magnet will be implanted for the amount of time required to correct the pectus excavatum deformity.
How much school will my child or I miss?
There are regular monthly appointments required and you or your child may have to miss school in order to attend these appointments. We will make every attempt to coordinate these visits with your or your child's schedule.
How much of my time will this treatment and the study take?
An estimate of how long and what will occur at each appointment is described below:
- Operation to place or remove the device is about a half day event. You or your child will come to UCSF for the surgery that will take about 45 minutes and then recover from anesthesia which will take anywhere from 2 to 5 hours.
- First month after the device is placed; you or your child will need to be seen weekly for a 20minute office visit.
- Starting at one month after the device is placed, you or your child will need to come to UCSF for a monthly chest x-ray which will take about 15 minutes 20 minutes, a monthly 20 minute office visit with the study team, and possibly a 20 to 30 minute office visit with the orthotist if any corrections are needed for the brace.
- One month after the device is removed, you or your child will be seen to obtain a chest CT scan and then a 20 minute office visit with the study team.
- At 6, 12, 18, and 24 months, you or your child will be seen for a 20 minute office visit with the study team.
Where will the treatment and follow-up visits take place?
All consultations and follow-up visits will be in the Pectus Clinic in the Pediatric Surgery Office located on the first floor of the UCSF Ambulatory Care Center. The address is 400 Parnassus Avenue, Room A-123. The surgeons, study nurse, and orthotist will be present to see you. If necessary, you may need to have adjustments made in the Orthotics and Prosthetics Center located across the street at 521 Parnassus Avenue, Room C-39.
The surgeries to place and remove the magnet implant will take place at the UCSF Surgery Center, which is very close to the Pectus Clinic Office.
Can my child or I stop being in the study?
Yes. Your child or you can decide to stop participating in the study at any time. The study doctors or nurse may also stop your participation in the study, if they believe it is in your or your child's best interest to do so.
If we will be flying in the future, will the magnet set off a metal detector?
This is a possibility. As with any implanted metal device, there is a potential problem that the Magnetic Mini-Mover might be detected by metal screening devices, such as those found in airport security. You and your child will be given a letter to keep that explains that your child has an implanted metallic device.
If the procedure doesn't work, will my child or I need a second, standard type of operation (Ravitch or Nuss)?
The pull on the sunken breastbone may not completely correct the chest deformity in the time that you or your child is willing to wear the magnetic brace. If this proved to be the case, you could always choose another form of treatment.
What are the other choices besides taking part in this study?
Other choices include:
- To receive no treatment; the pectus deformity will remain uncorrected.
- To receive standard treatment (e.g., Nuss procedure or the modified Ravitch procedure).
- If you do enroll in the study, you can decide to stop participation at any time.
What can I expect to pay for the procedure?
The cost of the EKG's and chest x-rays will be paid from study funding, and you will not be billed for these tests. Your insurance company will be billed for the costs of office visits, both surgeries, and any additional tests required to provide care for you or your child. You will be responsible for any co-payments and other deductibles you insurance requires you to pay.
Will my insurance company pay for this procedure?
In the past, some insurance companies have argued that they will not cover repair of pectus excavatum because it is "cosmetic." This is not true. Pectus excavatum is a congenital deformity with measurable effects on lung and heart function, so insurance companies must cover the cost of repair.
The study doctors will not perform this procedure unless pre-approval has been obtained from your insurance company.
The estimated total cost for repair of pectus excavatum by either of the two available surgical techniques is roughly $50,000-$80,000. The estimated total cost for repair using this new technique is between $15,000-$40,000; thus, saving money for the insurance companies.
How can I join the trial?
The multicenter clinical trial is now closed