NCT03710278

The Effectiveness and Safety of Human Lumbar Puncture Assist Device (LPat)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Spartanburg Regional Healthcare System · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to proof and investigate the effectiveness and safety of the invented device named "Human Lumbar Puncture Assist Device (LPat)" as an assist tool to be utilized to improve the success rate of performing lumbar puncture (LP), avoid side effects from multiple punctures, avoid excess radiation if the LP need to be done under fluoroscopy, and need to obtain none traumatic tap for better CSF analysis.

Detailed description

"Human Lumbar Puncture Assist Device (LPat)" was invented as an assist tool to be utilized to improve the success rate of performing lumbar puncture (LP), avoid side effects from multiple punctures, avoid excess radiation.

Conditions

• Meningitis
• Encephalitis
• Guillain-Barré
• Subarachnoid Hemorrhage
• Intracranial Neoplasm
• Intracranial CNS Disorder

Interventions

Type	Name	Description
DEVICE	LPat Device	Performing Lumbar Puncture utilizing LPat device

Timeline

• Start date: 2017-12-21
• Primary completion: 2019-01-23
• Completion: 2019-01-23
• First posted: 2018-10-18
• Last updated: 2019-09-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study