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

Launched by UNIVERSITY OF KANSAS MEDICAL CENTER · Nov 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Longeviti ClearFit Implant, which is designed to improve care for patients with chronic subdural hematomas—a condition where blood collects between the brain and its outer covering, often requiring surgery to drain the fluid. Traditionally, after surgery, patients need multiple CT scans to check for any fluid buildup, which can expose them to high radiation and increase medical costs. The Longeviti ClearFit Implant allows doctors to use ultrasound, a safer and faster imaging method, to monitor these patients without the need for repeated CT scans. This trial will compare the outcomes of patients who receive this new implant with those who receive the standard titanium cover.

To participate in this trial, you must be an adult over 18 years old and have a chronic subdural hematoma that requires surgery where the ClearFit cover can be used. Unfortunately, children and people allergic to the material of the implant cannot take part. If you join the study, you can expect close monitoring with ultrasound after your surgery, which aims to reduce the need for CT scans and lower overall treatment costs. This trial is not yet recruiting participants, but it represents an exciting step towards improving care for patients with this condition.

Gender

ALL

Eligibility criteria

• 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)