Multicenter Trial of Magnetic Mini-Mover for Pectus Excavatum

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

November 30, 2016

Study Completion Date

May 31, 2018

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.

Trial Locations (3)

64108

Children's Mercy Hospitals, Kansas City

94158

UCSF-Benioff Children's Hospital, San Francisco

95817

Shriners Hospitals for Children, Sacramento

All Listed Sponsors
collaborator

Shriners Hospitals for Children

OTHER

collaborator

Children's Mercy Hospital Kansas City

OTHER

lead

Michael Harrison

OTHER

NCT01327274 - Multicenter Trial of Magnetic Mini-Mover for Pectus Excavatum | Biotech Hunter | Biotech Hunter