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Chronic Subdural HematomaNCT06127615

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

A study testing ClearFit in people with Chronic Subdural Hematoma, run by University of Kansas Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Subdural Hematoma
What is being tested?
ClearFit
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2024to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

About this study

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.

Being tested
ClearFit
Medical subject headings
Hematoma, Subdural, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClearFitDevice

    Implantation of ClearFit Longeviti Craniectomy Cover

Study groups in NCT06127615
Study groupRoleWhat they receive
ClearFit Longeviti ImplantExperimentalPatients 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
Receives: Device: ClearFit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Radiation

    Amount of radiation exposure to patient with ClearFit obtaining ultrasounds rather than CT compared to retrospective control group

    Measured: from time of implant to last follow-up, anticipate 1 year

  2. Patient cost

    Overall cost to patient with ClearFit compared to retrospective control group

    Measured: from time of implant to last follow-up, anticipate 1 year

Secondary outcomes (2)

  1. Quality of imaging

    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

    Measured: from time of implant to last follow-up, anticipate 1 year

  2. Provider experience caring for patient

    Survey of ease to care for patient in post-operative time period, ultrasound for imaging, transport of patient to obtain imaging, ease of access

    Measured: from time of implant to last follow-up, anticipate 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study startDec 2024 (estimated)
  3. Primary completionNov 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Why it stopped: This study did not enroll participants

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06127615
Sponsor's protocol ID
UKansasClearFit
Status last verified
Mar 2025
First submitted
3 Oct 2023
Last updated
8 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Belzberg M, Shalom NB, Yuhanna E, Manbachi A, Tekes A, Huang J, Brem H, Gordon CR. Sonolucent Cranial Implants: Cadaveric Study and Clinical Findings Supporting Diagnostic and Therapeutic Transcranioplasty Ultrasound. J Craniofac Surg. 2019 Jul;30(5):1456-1461. doi: 10.1097/SCS.0000000000005454.

    PubMed 31299743

  • Belzberg M, Shalom NB, Lu A, Yuhanna E, Manbachi A, Tekes A, Huang J, Brem H, Gordon C. Transcranioplasty Ultrasound Through a Sonolucent Cranial Implant Made of Polymethyl Methacrylate: Phantom Study Comparing Ultrasound, Computed Tomography, and Magnetic Resonance Imaging. J Craniofac Surg. 2019 Oct;30(7):e626-e629. doi: 10.1097/SCS.0000000000005651.

    PubMed 31188246

  • Hadley C, North R, Srinivasan V, Kan P, Burkhardt JK. Elective Sonolucent Cranioplasty for Real-Time Ultrasound Monitoring of Flow and Patency of an Extra- to Intracranial Bypass. J Craniofac Surg. 2020 May/Jun;31(3):622-624. doi: 10.1097/SCS.0000000000006225.

    PubMed 32149973

  • Flores AR, Srinivasan VM, Seeley J, Huggins C, Kan P, Burkhardt JK. Safety, Feasibility, and Patient-Rated Outcome of Sonolucent Cranioplasty in Extracranial-Intracranial Bypass Surgery to Allow for Transcranioplasty Ultrasound Assessment. World Neurosurg. 2020 Dec;144:e277-e284. doi: 10.1016/j.wneu.2020.08.114. Epub 2020 Aug 20.

    PubMed 32827747

  • Lee RP, Meggyesy M, Ahn J, Ritter C, Suk I, Machnitz AJ, Huang J, Gordon C, Brem H, Luciano M. First Experience With Postoperative Transcranial Ultrasound Through Sonolucent Burr Hole Covers in Adult Hydrocephalus Patients. Neurosurgery. 2023 Feb 1;92(2):382-390. doi: 10.1227/neu.0000000000002221. Epub 2022 Nov 15.

    PubMed 36637272

  • Doron O, D'Amico RS, Langer DJ. The Cranial Window: Opportunities for the Use of Bedside Ultrasound Facilitated by Sonolucent Implants in Neurosurgical Patients. World Neurosurg. 2022 Sep;165:142-144. doi: 10.1016/j.wneu.2022.05.084. Epub 2022 May 23. No abstract available.

    PubMed 35926403

  • Niesen WD, Rosenkranz M, Weiller C. Bedsided Transcranial Sonographic Monitoring for Expansion and Progression of Subdural Hematoma Compared to Computed Tomography. Front Neurol. 2018 May 28;9:374. doi: 10.3389/fneur.2018.00374. eCollection 2018.

    PubMed 29892260

Questions about this trial

What is this clinical trial studying?

A study testing ClearFit in people with Chronic Subdural Hematoma, run by University of Kansas Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Radiation (time frame: from time of implant to last follow-up, anticipate 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06127615, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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