The Effectiveness and Safety of Human Lumbar Puncture Ass... | NCT03710278

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

NCT03710278

Sponsor

Spartanburg Regional Healthcare System

Status

Completed

Last Update Posted

Sep 18, 2019Actual

Enrollment

5Actual

Phase

Not provided

Conditions

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

Interventions

LPat Device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 21, 2017Actual

Primary Completion Date

Jan 23, 2019Actual

Completion Date

Jan 23, 2019Actual

First Submitted Date

Oct 8, 2018

First Submission Date that Met QC Criteria

Oct 15, 2018

First Posted Date

Oct 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2019

Last Update Posted Date

Sep 18, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hanna S. Sahhar, Medical Director, PICU, Spartanburg Regional Healthcare SystemPrincipal Investigator

Lead Sponsor

Spartanburg Regional Healthcare SystemOTHER

Collaborators

Name	Class
Edward Via Virginia College of Osteopathic Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LPat Device		Performing Lumbar Puncture assisted by LPat	Device: LPat Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LPat Device	Device	Performing Lumbar Puncture utilizing LPat device	LPat Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful Lumbar Puncture	Obtain CSF	Immediate

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Any patient 12 years or older

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Spartanburg Reginal Heathcare System		Spartanburg	South Carolina	29303	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008581	Meningitis
D004660	Encephalitis
D020275	Guillain-Barre Syndrome
D013345	Subarachnoid Hemorrhage
D001932	Brain Neoplasms
D001927	Brain Diseases

Ancestor Terms

ID	Term
D000090862	Neuroinflammatory Diseases
D009422	Nervous System Diseases
D002493	Central Nervous System Diseases
D011129	Polyradiculoneuropathy

Browse Leaves

Not provided

Browse Branches

Not provided