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Multicenter Trial of Magnetic Mini-Mover for Pectus Excavatum (3MP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Shriners Hospitals for Children
Children's Mercy Hospital Kansas City
Information provided by (Responsible Party):
Michael Harrison, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01327274
First received: March 30, 2011
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention Phase
Pectus Excavatum
Device: Magnetic Mini-Mover Procedure (Magnimplant)
Phase 3

Study Type: Interventional
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

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 15
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)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   8 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327274

Locations
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
Sponsors and Collaborators
Michael Harrison
Shriners Hospitals for Children
Children's Mercy Hospital Kansas City
Investigators
Study Director: Michael R Harrison, MD University of California, San Francisco
Principal Investigator: Shinjiro Hirose, MD University of California, San Francisco
  More Information

Additional Information:
Publications:
Responsible Party: Michael Harrison, Professor of Surgery and Pediatrics, Emeritus, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01327274     History of Changes
Other Study ID Numbers: FD003341-03-06, FD-R-01FD-03341-01
Study First Received: March 30, 2011
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration
United States: UCSF Committee on Human Research/Human Research Protection Program
United States: 3MP Data and Safety Monitoring Board

Keywords provided by University of California, San Francisco:
Pectus excavatum
Chest wall deformity
Magnetic Mini-Mover Procedure
Pectus Severity Index
pediatric medical device
magnetic alteration
sunken chest

Additional relevant MeSH terms:
Funnel Chest
Bone Diseases
Bone Diseases, Developmental
Congenital Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 24, 2014