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NCT03710278 Clinical Trial

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

Subarachnoid Hemorrhage Clinical Trial

— LPat  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03710278
Other study ID # Pro00073159
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 21, 2017
Est. completion date January 23, 2019

Study information
Verified date September 2019
Source Spartanburg Regional Healthcare System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date January 23, 2019
Est. primary completion date January 23, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• LPat Device
Performing Lumbar Puncture utilizing LPat device

Locations
Country Name City State
United States Spartanburg Reginal Heathcare System Spartanburg South Carolina

Sponsors (2)
Lead Sponsor Collaborator
Spartanburg Regional Healthcare System Edward Via Virginia College of Osteopathic Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Successful Lumbar Puncture Obtain CSF Immediate
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