Multicenter Trial of Magnetic Mini-Mover for Pectus Excavatum

NCT01327274 | Completed Results DMC

• 2 other identifiers: FD003341-03-06FD-R-01FD-03341
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Pectus Excavatum

Keywords

Pectus excavatum; Chest wall deformity; Magnetic Mini-Mover Procedure; Pectus Severity Index; pediatric medical device; magnetic alteration; sunken chest

Outcome Measures

Primary Outcomes (1)

• 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).

  During treatment, 24 months

Secondary Outcomes (3)

• Comfort and Brace Wear During Treatment

  During treatment, 24 months

• Chest Wall Correction, by Pectus Severity Index

  24 months

• Patient Satisfaction During the Treatment

  One month and one year after explant.

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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)

Interventions

Magnetic Mini-Mover Procedure (Magnimplant) DEVICE

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

Treatment Arm

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael Harrison: lead
• Shriners Hospitals for Children: collaborator
• Children's Mercy Hospital Kansas City: collaborator

Study Sites (3)

Shriners Hospitals for Children

Sacramento, California, 95817, United States

Location

UCSF-Benioff Children's Hospital

San Francisco, California, 94158, United States

Location

Children's Mercy Hospitals

Kansas City, Missouri, 64108, United States

Location

Related Publications (3)

• Harrison MR, Curran PF, Jamshidi R, Christensen D, Bratton BJ, Fechter R, Hirose S. Magnetic mini-mover procedure for pectus excavatum II: initial findings of a Food and Drug Administration-sponsored trial. J Pediatr Surg. 2010 Jan;45(1):185-91; discussion 191-2. doi: 10.1016/j.jpedsurg.2009.10.032.

  PMID: 20105602 BACKGROUND

• Harrison MR, Estefan-Ventura D, Fechter R, Moran AM Jr, Christensen D. Magnetic Mini-Mover Procedure for pectus excavatum: I. Development, design, and simulations for feasibility and safety. J Pediatr Surg. 2007 Jan;42(1):81-5; discussion 85-6. doi: 10.1016/j.jpedsurg.2006.09.042.

  PMID: 17208545 BACKGROUND

• Harrison MR, Gonzales KD, Bratton BJ, Christensen D, Curran PF, Fechter R, Hirose S. Magnetic mini-mover procedure for pectus excavatum III: safety and efficacy in a Food and Drug Administration-sponsored clinical trial. J Pediatr Surg. 2012 Jan;47(1):154-9. doi: 10.1016/j.jpedsurg.2011.10.039.

  PMID: 22244409 BACKGROUND

Related Links

• Magnetic Mini-Mover Procedure (3MP) Trial

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Jill Imamura-Ching, RN
• Organization: UCSF Benioff Children's Hospital

Jill.Imamura-Ching@ucsf.edu

415-476-3446

Study Officials

• Michael R Harrison, MD

  University of California, San Francisco

  STUDY DIRECTOR

• Benjamin Padilla, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Lan Vu, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery and Pediatrics, Emeritus

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 1, 2011
• Study Start: December 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: May 1, 2018
• Last Updated: November 8, 2018
• Results First Posted: May 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)