Efficacy and Safety of 3D-Printed PEEK Skull Implants in Cranioplasty

NAEnrolling by invitationINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

October 31, 2025

Study Completion Date

September 30, 2026

Conditions
Cranial Defects
Interventions
PROCEDURE

cranioplasty

In this pivotal study of a medical device, patients with bone loss undergo a computed tomography scan, which is used to create a three-dimensional model of the lesion. After validation, the model is printed using PEEK material, and subsequently, the skull is repaired through cranial reconstruction (cranioplasty).

DEVICE

customized skull implants made of polyetheretheretherketone (PEEK) using 3D printing

customized skull implants made of polyetheretheretherketone by three-dimensional printing in patients undergoing cranioplasty

Trial Locations (1)

44340

Centro de Investigación Clínica y Medicina Traslacional (CIMET), Guadalajara

All Listed Sponsors
collaborator

Consejo Nacional de Humanidades, Ciencias y Tecnologias (CONAHCYT)

UNKNOWN

lead

CIMET SCIENTIFIC CORPORATION

OTHER