An interventional study of Magnetic Mini-Mover Procedure (Magnimplant) in Pectus Excavatum, sponsored by Michael Harrison. Completed at 3 sites in United States. Open to participants aged 8 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-08.
Sponsored by Michael Harrison · Not applicable, Interventional, and Treatment
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).
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.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's enrollment of 15 is below the median of 40 across 46 interventional studies indexed under Funnel Chest.
Browse Funnel Chest studies →Michael Harrison is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a non-randomized study in which otherwise healthy patients, ages 8-14, with severe pectus excavatum (PSI \> 3.5) will undergo the interventional treatment arm by having outpatient surgery and the Magnetic MIni-Mover Magnimplant procedure is performed during which the magnetic implant is surgically placed. After 2 years of treatment with the implanted magnet and brace treatment, the Magnetic Mini-Mover Magnimplant will be explanted. After surgery and recovery, all subjects 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 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.
Also known as: IDE G090006
Number of Participants With Adverse Reactions
All adverse reactions were recorded and reported, 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).
Time frame: During treatment, 24 months
Comfort and Brace Wear During Treatment
Comfort of the external brace directly affects compliance (i.e., bracewear) and compliance were 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.
Time frame: During treatment, 24 months
Chest Wall Correction, by Pectus Severity Index
Though not powered to determine efficacy, preliminary efficacy data, as measured by pre and post treatment Pectus Severity Index (Haller Index), was also collected. Pre-treatment Haller Index was assessed based on computed tomography (CT) of the chest. One month after implant removal, patients underwent repeat chest CT to evaluate chest wall correction.
Time frame: 24 months
Patient Satisfaction During the Treatment
. Patients were asked to fill out questionnaire at 2 intervals: 1 month after explant and 1 year after explant
Time frame: One month and one year after explant.
| Milestone | Treatment Arm |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
All adverse reactions were recorded and reported, 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).
| Participants | Treatment Arm |
|---|---|
| Discharge home same day | 13 |
| Normal EKG after implant of magnet | 15 |
| Surgical site infection | 14 |
| Intact cables for implant placement | 8 |
Comfort of the external brace directly affects compliance (i.e., bracewear) and compliance were 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.
| Participants | Treatment Arm |
|---|---|
| Discomfort | 5 |
| Tolerated Brace wear | 10 |
Though not powered to determine efficacy, preliminary efficacy data, as measured by pre and post treatment Pectus Severity Index (Haller Index), was also collected. Pre-treatment Haller Index was assessed based on computed tomography (CT) of the chest. One month after implant removal, patients underwent repeat chest CT to evaluate chest wall correction.
| Participants | Treatment Arm |
|---|---|
| Improved | 5 |
| No change | 2 |
| Worsened | 7 |
. Patients were asked to fill out questionnaire at 2 intervals: 1 month after explant and 1 year after explant
| Participants | Treatment Arm |
|---|---|
| Recommend 3MP after 1 month | 11 |
| Recommend 3MP after 1 year | 11 |
| Satisfaction with results at 1 month | 9 |
| Satisfaction with results after 1 year | 8 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Arm | 0/15 (0%) | 2/15 (13.3%) | 4/15 (26.7%) |
| Event | Treatment Arm |
|---|---|
| Acute cable breakage requiring urgent explantProduct Issues | 1/15 |
| Nonacute cable breakage requiring explantCardiac disorders | 1/15 |
| Event | Treatment Arm |
|---|---|
| Post-procedure hospitalization for pain controlSurgical and medical procedures | 1/15 |
| Wound infectionSkin and subcutaneous tissue disorders | 1/15 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 1/15 |
| RashSkin and subcutaneous tissue disorders | 1/15 |
| Age, Continuous(years) | Treatment Arm |
|---|---|
| Mean | 12 (8 to 14) |
| Sex: Female, Male(Participants) | Treatment Arm |
|---|---|
| Female | 2 |
| Male | 13 |
| Race and Ethnicity Not Collected(Participants) | Treatment Arm |
|---|
| Pectus Severity Index (Haller Index)(Ratio) | Treatment Arm |
|---|---|
| Mean | 4.7 (3.6 to 7.4) |
Plan to share: No — The end results will be published in Journal of Pediatric Surgery June 2017
Ran from Dec 2011 to primary completion in Nov 2016, 59 months.
Results were first posted in May 2018, 1 year 6 months after primary completion.
Of 31 interventional studies with no phase under Funnel Chest, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 68. This study's 59 months is above that.
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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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