N/A
N=15
Multicenter Trial of Magnetic Mini-Mover for Pectus Excavatum
Pectus Excavatum
Bottom Line
View on ClinicalTrials.gov: NCT01327274 ↗Enrolled (actual)
15
Serious AEs
13.3%
Results posted
May 2018
Primary outcome: Primary: Number of Participants With Adverse Reactions — 13; 15; 14; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Magnetic Mini-Mover Procedure (Magnimplant) (Device)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Michael Harrison
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Reactions |
13; 15; 14; 8 | — |
| SECONDARY Comfort and Brace Wear During Treatment |
5; 10 | — |
| SECONDARY Chest Wall Correction, by Pectus Severity Index |
5; 2; 7 | 0.486 |
| SECONDARY Patient Satisfaction During the Treatment |
11; 11; 9; 8 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Otherwise healthy male or female with pectus excavatum deformity
- Between 8 and 14 years of age (inclusive)
- Pectus Severity Index > 3.5 (normal 2.56). NOTE: A pectus severity index of 3.5 or greater qualifies as a moderate-to-severe deformity, and justifies operative intervention
- Ability to read, speak and understand English
- Onset of rapid growth of puberty documented by hand/wrist x-ray in early to mid-puberty (defined as bone age in females of 7-13 years, and males of 9-14 years)
Exclusion Criteria
- Other congenital anomalies (including significant skeletal anomalies such as scoliosis, bony fusion involving the cervical vertebrae) not directly related to pectus excavatum
- Bleeding disorders
- Heart disease (including arrhythmia)
- Persons with active implantable medical devices (AIMD) such as pacemakers
- Persons with a relative(s) or close family friend(s) living within their households and having a pacemaker
- Persons with arteriovenous malformations
- Chest deformity more complicated than pectus excavatum (e.g., Poland syndrome)
- Persons for whom a foreign body implant would pose a risk (e.g., immunodeficiency)
- Persons at increased risk for general anesthesia (e.g., history of malignant hyperthermia)
- Respiratory conditions that have required steroid treatment (e.g., prednisone) in the last 3 years
- Pregnancy
- Inability to understand or follow instructions
- Refusal to wear the external brace
- Refusal to undergo monthly chest x-rays
- Inability or refusal to return to UCSF for biweekly follow-up visits for the first month after surgery, and monthly thereafter until explant.
- Inability to obtain pre-approval (authorization) from the patient's insurance carrier
Data sourced from ClinicalTrials.gov (NCT01327274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.