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

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.

Study Overview

• Status: Completed
• Conditions: Encephalitis; Meningitis; Subarachnoid Hemorrhage; Intracranial Neoplasm; Guillain-Barré; Intracranial CNS Disorder
• Intervention / Treatment: Device: LPat Device

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 Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Reginal Heathcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient 12 years or older

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LPat Device; Performing Lumbar Puncture assisted by LPat	Device: LPat Device; Performing Lumbar Puncture utilizing LPat device; Other Names: Lumbar Puncture Assisted by LPat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Lumbar Puncture	Obtain CSF	Immediate

Collaborators and Investigators

• Sponsor: Spartanburg Regional Healthcare System
• Collaborators: Edward Via Virginia College of Osteopathic Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 21, 2017
• Primary Completion (ACTUAL): January 23, 2019
• Study Completion (ACTUAL): January 23, 2019

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (ACTUAL): October 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Neoplasms; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neoplasms by Site; Neuromuscular Diseases; Peripheral Nervous System Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Intracranial Hemorrhages; Polyradiculoneuropathy; Polyneuropathies; Encephalitis; Hemorrhage; Brain Neoplasms; Brain Diseases; Meningitis; Subarachnoid Hemorrhage; Guillain-Barre Syndrome
• Other Study ID Numbers: Pro00073159

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes