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

NCT03710278 | Completed DMC FDA Device

• 1 other identifier: Pro00073159
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Successful Lumbar Puncture

  Obtain CSF

  Immediate

Study Arms (1)

LPat Device

Performing Lumbar Puncture assisted by LPat

Device: LPat Device

Interventions

LPat Device DEVICE

Performing Lumbar Puncture utilizing LPat device

Also known as: Lumbar Puncture Assisted by LPat

LPat Device

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient 12 years or older

You may qualify if:

• 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"

You may not qualify if:

• Patients younger than 12 years of age

Sponsors & Collaborators

• Spartanburg Regional Healthcare System: lead
• Edward Via Virginia College of Osteopathic Medicine: collaborator

Study Sites (1)

Spartanburg Reginal Heathcare System

Spartanburg, South Carolina, 29303, United States

Location

MeSH Terms

Conditions

Meningitis; Encephalitis; Guillain-Barre Syndrome; Subarachnoid Hemorrhage; Brain Neoplasms; Brain Diseases

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Central Nervous System Diseases; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, PICU

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 18, 2018
• Study Start: December 21, 2017
• Primary Completion: January 23, 2019
• Study Completion: January 23, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)