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

NCT ID: NCT03710278

Last Updated: 2019-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-21

Study Completion Date

2019-01-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

"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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LPat Device

Performing Lumbar Puncture assisted by LPat

LPat Device

Intervention Type DEVICE

Performing Lumbar Puncture utilizing LPat device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LPat Device

Performing Lumbar Puncture utilizing LPat device

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lumbar Puncture Assisted by LPat

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Edward Via Virginia College of Osteopathic Medicine

OTHER

Sponsor Role collaborator

Spartanburg Regional Healthcare System

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hanna S. Sahhar

Medical Director, PICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Spartanburg Reginal Heathcare System

Spartanburg, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00073159

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

iBCI Optimization for Veterans With Paralysis
NCT05470478 NOT_YET_RECRUITING NA
Improving Walking After Spinal Cord Injury
NCT07223710 NOT_YET_RECRUITING PHASE1/PHASE2