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

NCT06782711 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-01-20

No results posted yet for this study

Summary

The goal of this clinical trial is to determine the efficacy and safety of customized skull implants made of polyetheretheretherketone by three-dimensional printing in patients undergoing cranioplasty. The main question it aims to answer is:

• Are customized skull implants made of polyetheretheretherketone using 3D printing effective and safe in patients undergoing cranioplasty?

Participants will:

* The patient will be submitted to cranioplasty.
* The patient will answer the neurological scales at each visit.
* Keep a diary of their symptoms and concomitant medications
* The study will be divided into 5 visits to the center, the surgical intervention and 3 telephone calls where patients will be followed up.

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

Sponsors & Collaborators

  • Consejo Nacional de Humanidades, Ciencias y Tecnologias (CONAHCYT)

    collaborator UNKNOWN

  • CIMET SCIENTIFIC CORPORATION

    lead OTHER

Principal Investigators

  • Geannyne Villegas Rivera, MD, PhD, MBA · Centro de Investigación Clínica y Medicina Traslacional (CIMET)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2025-10-31
Completion
2026-09-30

Countries

  • Mexico

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 NCT06782711 on ClinicalTrials.gov