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Multicenter Trial of Magnetic Mini-Mover for Pectus Excavatum

NCT01327274 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-11-08

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Shriners Hospitals for Children

    collaborator OTHER

  • Children's Mercy Hospital Kansas City

    collaborator OTHER

  • Michael Harrison

    lead OTHER

Principal Investigators

  • Michael R Harrison, MD · University of California, San Francisco

  • Benjamin Padilla, MD · University of California, San Francisco

  • Lan Vu, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2016-11-30
Completion
2018-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01327274 on ClinicalTrials.gov