Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466206
Status:
COMPLETED
Last Update Posted:
2016-01-01
First Post:
2007-04-24
Brief Title:
Magnetic Mini-Mover Procedure to Treat Pectus Excavatum
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Phase II Magnetic Alteration of Pectus Excavatum
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
3MP
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 then applying an external magnetic force that will pull the sternum outward gradually
Potential candidates for this study are children and adolescents with a previously diagnosed congenital pectus excavatum sunken chest deformity who are otherwise healthy and are seeking corrective surgery for their condition They will be residents of the US and between the ages of 8 and 14 years of age Potential candidates and their families will have already been counseled about this condition and about the standard way to repair this deformity
The purpose of this study is to test what effects good andor bad placing an externalinternal magnetic device has on correcting pectus excavatum deformity in children and the safety of using such a device for treatment
The study investigators have developed a method to gradually repair pectus excavatum sunken chest deformity by placing a magnet on the sternum breastbone and then applying an external magnetic force that will pull the sternum outward gradually
Potential candidates for this study are children and adolescents with a previously diagnosed congenital pectus excavatum sunken chest deformity who are otherwise healthy and are seeking corrective surgery for their condition They will be residents of the US and between the ages of 8 and 14 years of age Potential candidates and their families will have already been counseled about this condition and about the standard way to repair this deformity
The purpose of this study is to test what effects good andor bad placing an externalinternal magnetic device has on correcting pectus excavatum deformity in children and the safety of using such a device for treatment
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 in place using a metal chest wall strut Deformation of the chest wall under great pressure may result in complications and potential relapses as well as postoperative pain requiring hospitalization for regional and narcotic anesthesia for up to a week An alternative principle for correction of chest wall and other deformities is gradual bit-by-bit correction using minimal force applied over many months like moving teeth with orthodontic braces
The hypothesis of this study is that constant outward force on the deformed cartilage in pectus excavatum will produce biologic reformation of cartilage and correction of the chest wall deformity
The study investigators have developed a novel method of achieving gradual deformationreformation of chest wall cartilage without the need for transdermal orthopedic devices or repeated surgeries A magnetic force field is used to apply controlled sustained force to promote biologic reformation of structural cartilage the same principle as distraction osteogenesis A magnet is implanted on the sternum and secured using a novel fixation strategy that can be accomplished through a 3-cm subxyphoid incision as a brief outpatient procedure The magnet and sternum is pulled outward by another magnet suspended in a novel low-profile lightweight device previously molded to the patients anterior chest wall The external magnet allows individual adjustment in small increments of the distance and thus force and orientation of the force applied to the sternum The low-profile non-obtrusive anterior chest wall prosthesis is held in place by the force field between the two magnets
The study objectives are to test the safety and probable benefit of this procedure in 10 otherwise healthy young patients between 8 years and 14 years of age who have chosen to have this deformity corrected using this novel technique rather than the standard Ravitch or Nuss techniques We will document the rate of correction by chest imaging and measurement of the Pectus Severity Index The study investigators will document safety and efficacy with an EKG prior to implantation one month post-implantation and finally after the magnet is removed as well as patient and family satisfaction with a post-procedure Quality of Life-type survey
The hypothesis of this study is that constant outward force on the deformed cartilage in pectus excavatum will produce biologic reformation of cartilage and correction of the chest wall deformity
The study investigators have developed a novel method of achieving gradual deformationreformation of chest wall cartilage without the need for transdermal orthopedic devices or repeated surgeries A magnetic force field is used to apply controlled sustained force to promote biologic reformation of structural cartilage the same principle as distraction osteogenesis A magnet is implanted on the sternum and secured using a novel fixation strategy that can be accomplished through a 3-cm subxyphoid incision as a brief outpatient procedure The magnet and sternum is pulled outward by another magnet suspended in a novel low-profile lightweight device previously molded to the patients anterior chest wall The external magnet allows individual adjustment in small increments of the distance and thus force and orientation of the force applied to the sternum The low-profile non-obtrusive anterior chest wall prosthesis is held in place by the force field between the two magnets
The study objectives are to test the safety and probable benefit of this procedure in 10 otherwise healthy young patients between 8 years and 14 years of age who have chosen to have this deformity corrected using this novel technique rather than the standard Ravitch or Nuss techniques We will document the rate of correction by chest imaging and measurement of the Pectus Severity Index The study investigators will document safety and efficacy with an EKG prior to implantation one month post-implantation and finally after the magnet is removed as well as patient and family satisfaction with a post-procedure Quality of Life-type survey
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None