Bone Flap Fixation Systems For Craniotomy Procedures

NCT04859907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-08-01

No results posted yet for this study

Summary

Clinical investigation to compare the clinical safety and performance of a clamp-like device for craniotomy closure, with the standard of care system, titanium plates and screws.

Conditions

  • Craniotomy

Interventions

DEVICE

Clamp-like system

Craniotomy closure

DEVICE

Plates and screws

Craniotomy closure

Sponsors & Collaborators

  • NEOS Surgery

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-19
Primary Completion
2022-11-19
Completion
2023-02-16

Countries

  • Slovenia
  • Spain

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 NCT04859907 on ClinicalTrials.gov