The Efficacy of the Longeviti ClearFit Implant in Craniectomies for Post-Operative Monitoring in Chronic Subdural Hematomas

July 2, 2025 updated by: University of Kansas Medical Center
Chronic subdural hematomas are frequent neurosurgical issues that are most often treated with burr hole craniectomies to drain the subdural fluid. At the chronic stage, a subdural hematoma is more liquified and easily washed out through burr hole openings. However, it often requires frequent imaging and monitoring to ensure that fluid does not reaccumulate in the subdural space, that the washout was adequate, and that further intervention/repeat intervention is not required, particularly if the patient develops acute changes in neurologic status or lacks improvement in initial symptomatology. Therefore, these patients require multiple repeated CT head images during their inpatient and post-operative follow-up course. This leads to high radiation doses to patients and high-cost burden. The Longeviti ClearFit Cover was developed to allow for ultrasound imaging through the implanted cover. The skull's acoustic properties prevent ultrasound from being used through the bone, therefore limiting its use in post-operative neurosurgical patients. Using ultrasound would remove the need for high radiation doses with CT, could be done very quickly and easily at bedside or in the clinic to check subdural space or ventricle size, and is much lower cost. This ClearFit implant would be utilized in place of a burr hole cover, typically titanium, that is implanted in most other cases. The aim of this study is to prospectively assess patients with surgically treated chronic subdural hematomas via craniectomy that have the craniectomy site covered with the Longeviti ClearFit, compared retrospectively to a matched cohort of patients that had their craniectomy site for the same procedure covered with the typically used titanium/metal. This will allow us to determine if this new implant results in reduced need for repeated CT imaging by utilizing bedside clinician-performed ultrasound and reduces overall cost for patients.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients >18 years old; patients determined by surgeon to have a chronic subdural hematoma that is treated with craniectomy that would allow for implantation of a ClearFit cover

Exclusion Criteria:

  • Pediatric patients, patient with allergy to the material the implant is made with (polymethylmethacrylate)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ClearFit Longeviti Implant
Patients with chronic subdural hematomas that qualify for study and agree to participate will receive the ClearFit implant to cover the craniectomy site and have ultrasound imaging for their post-operative follow-up rather than CT/MRI, with exception of first initial post-op CT scan, and crossover to CT/MRI if clinically indicated or required for diagnostic purposes/patient safety
Device: ClearFit
Implantation of ClearFit Longeviti Craniectomy Cover

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Radiation
Time Frame: from time of implant to last follow-up, anticipate 1 year
Amount of radiation exposure to patient with ClearFit obtaining ultrasounds rather than CT compared to retrospective control group
from time of implant to last follow-up, anticipate 1 year
Patient cost
Time Frame: from time of implant to last follow-up, anticipate 1 year
Overall cost to patient with ClearFit compared to retrospective control group
from time of implant to last follow-up, anticipate 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of imaging
Time Frame: from time of implant to last follow-up, anticipate 1 year
Calculated based on number of cross-overs from ultrasound to CT or MRI, with noted reason for crossover. Analysis of how often ultrasound is unable to be used/not feasible for post-operative monitoring of subdural, statistical analysis of crossover out of ultrasound into CT/MRI cranial imaging
from time of implant to last follow-up, anticipate 1 year
Provider experience caring for patient
Time Frame: from time of implant to last follow-up, anticipate 1 year
Survey of ease to care for patient in post-operative time period, ultrasound for imaging, transport of patient to obtain imaging, ease of access
from time of implant to last follow-up, anticipate 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 3, 2023

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKansasClearFit

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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