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

Chronic Subdural Hematoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06127615
• Other study ID #: UKansasClearFit
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: November 2025

Study information

• Verified date: November 2023
• Source: University of Kansas Medical Center
• Contact: Bailey Yekzaman, MD
• Phone: 3166131041
• Email: byekzaman[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Device:
• ClearFit
Implantation of ClearFit Longeviti Craniectomy Cover

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Radiation	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
Primary	Patient cost	Overall cost to patient with ClearFit compared to retrospective control group	from time of implant to last follow-up, anticipate 1 year
Secondary	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	from time of implant to last follow-up, anticipate 1 year
Secondary	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	from time of implant to last follow-up, anticipate 1 year

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