NCT04859907

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2023

Completed
Last Updated

August 1, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

April 15, 2021

Last Update Submit

July 28, 2023

Conditions

Craniotomy

Outcome Measures

Primary Outcomes (1)

  • Bone flap alignment score

    1-4

    6 months

Secondary Outcomes (6)

  • Frequency of adverse effects and device deficiencies (device safety)

    6 months

  • Bone-flap alignment score

    0-7 days after surgery (before discharge)

  • Surgeon usability questionnaire

    0 days after surgery

  • Device related artefacts in neuroimaging

    6 months

  • Device-related bulges or visible offsets

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Clamp-like system

EXPERIMENTAL
Device: Clamp-like system

Plates and screws

ACTIVE COMPARATOR
Device: Plates and screws

Interventions

Clamp-like systemDEVICE

Craniotomy closure

Also known as: Cranial LOOP
Clamp-like system
Plates and screwsDEVICE

Craniotomy closure

Plates and screws

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject is 18 years or older.
  • The subject can be implanted with the assigned craniotomy closure system according to its Instructions for Use.
  • At least one post-operative medical image (CT scan or Magnetic Resonance image) is planned to be performed.
  • Life expectancy higher than 6 months.
  • The subject is willing to give his/her informed consent and to comply with the required follow-up.

You may not qualify if:

  • The subject presents any of the contraindications of the assigned craniotomy closure system.
  • Orbitozygomatic or mastoid craniotomies.
  • Posterior fossa (skull base) surgeries.
  • Combined used of craniotomy systems (plates and clamps).
  • The subject is currently participating in an investigational drug or device study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Maribor University Medical Center

Maribor, Slovenia

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario la Paz

Madrid, 28046, Spain

Location

MeSH Terms

Interventions

Bone Plates

Intervention Hierarchy (Ancestors)

Internal FixatorsProstheses and ImplantsEquipment and SuppliesOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentSurgical Fixation Devices

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2021

First Posted

April 26, 2021

Study Start

March 19, 2021

Primary Completion

November 19, 2022

Study Completion

February 16, 2023

Last Updated

August 1, 2023

Record last verified: 2023-02

Locations

ES(2)SL(1)