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

Completed

• Conditions: Intracranial CNS Disorder; Encephalitis; Guillain-Barré; Subarachnoid Hemorrhage; Intracranial Neoplasm; Meningitis
• Interventions: Device: LPat Device

• Registration Number: NCT03710278
• Lead Sponsor: Spartanburg Regional Healthcare System

Brief 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.

Study Timeline

• Study Start: 2017-12-21
• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-18
• Primary Completion: 2019-01-23
• Study Completion: 2019-01-23
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Patients age 12 years and older who need lumbar puncture (LP) for diagnostic purposes or patients already underwent LP but failed to obtain Cerebrospinal Fluids i.e. "Unsuccessful Tap"

Exclusion Criteria

Patients younger than 12 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LPat Device	LPat Device	Performing Lumbar Puncture assisted by LPat

Primary Outcome Measures

Name	Time	Method
Successful Lumbar Puncture	Immediate	Obtain CSF

Trial Locations

Locations (1)

Spartanburg Reginal Heathcare System; 🇺🇸 Spartanburg, South Carolina, United States