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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03710278
Recruitment Status : Completed
First Posted : October 18, 2018
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
Edward Via Virginia College of Osteopathic Medicine
Information provided by (Responsible Party):
Hanna S. Sahhar, 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.

Condition or disease Intervention/treatment
Meningitis Encephalitis Guillain-Barré Subarachnoid Hemorrhage Intracranial Neoplasm Intracranial CNS Disorder 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.

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effectiveness and Safety of Human Lumbar Puncture Assist Device (LPat)
Actual Study Start Date : December 21, 2017
Actual Primary Completion Date : January 23, 2019
Actual Study Completion Date : January 23, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
LPat Device
Performing Lumbar Puncture assisted by LPat
Device: LPat Device
Performing Lumbar Puncture utilizing LPat device
Other Name: Lumbar Puncture Assisted by LPat




Primary Outcome Measures :
  1. Successful Lumbar Puncture [ Time Frame: Immediate ]
    Obtain CSF



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any patient 12 years or older
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03710278


Locations
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United States, South Carolina
Spartanburg Reginal Heathcare System
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Spartanburg Regional Healthcare System
Edward Via Virginia College of Osteopathic Medicine

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Responsible Party: Hanna S. Sahhar, Medical Director, PICU, Spartanburg Regional Healthcare System
ClinicalTrials.gov Identifier: NCT03710278     History of Changes
Other Study ID Numbers: Pro00073159
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Guillain-Barre Syndrome
Brain Neoplasms
Meningitis
Subarachnoid Hemorrhage
Encephalitis
Brain Diseases
Hemorrhage
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
Immune System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms