MeningitisLPatNCT03710278
The Effectiveness and Safety of Human Lumbar Puncture Assist Device (LPat)
An observational study of Meningitis and Encephalitis, run by Spartanburg Regional Healthcare System at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Encephalitis, Guillain-Barré
- What is being tested?
- LPat Device
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2017to 23 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Any patient 12 years or older
Who may be able to join
- 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"
Who cannot join
- Patients younger than 12 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Spartanburg Reginal Heathcare System
Spartanburg, South Carolina, 29303
About this study
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.
Read the 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.
- Conditions
- Meningitis, Encephalitis, Guillain-Barré, Subarachnoid Hemorrhage, Intracranial Neoplasm, Intracranial CNS Disorder
- Being tested
- LPat Device
- Medical subject headings
- Meningitis, Encephalitis, Guillain-Barre Syndrome, Subarachnoid Hemorrhage, Brain Neoplasms, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPat DeviceDevice
Also called Lumbar Puncture Assisted by LPat
Performing Lumbar Puncture utilizing LPat device
| Study group | Role | What they receive |
|---|---|---|
| LPat Device | Performing Lumbar Puncture assisted by LPat Receives: Device: LPat Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Lumbar Puncture
Obtain CSF
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start21 Dec 2017
- Primary completion23 Jan 2019
- Study completion23 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spartanburg Regional Healthcare System
- Sponsor type
- University, hospital or other
- Collaborators
- Edward Via Virginia College of Osteopathic Medicine
- Responsible party
- Principal investigator, Hanna S. Sahhar, Spartanburg Regional Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710278
- Sponsor's protocol ID
- Pro00073159
- Acronym
- LPat
- Status last verified
- Sep 2019
- First submitted
- 8 Oct 2018
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Human Lumbar Puncture Assist Device (LPat)
- ClinicalTrials.gov ID
- NCT03710278
- Acronym / sponsor ID
- LPat / Pro00073159
- Conditions
- Meningitis, Encephalitis, Guillain-Barré, Subarachnoid Hemorrhage, Intracranial Neoplasm, Intracranial CNS Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Spartanburg Regional Healthcare SystemUniversity, hospital or other
- Collaborators
- Edward Via Virginia College of Osteopathic Medicine
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 23 Jan 2019 (actual)
- Study completion
- 23 Jan 2019 (actual)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LPat Device | – | Device: LPat DevicePerforming Lumbar Puncture assisted by LPat |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient 12 years or older
Key inclusion criteria (1 listed)
- 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"
Key exclusion criteria (1 listed)
- Patients younger than 12 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LPat DeviceAlso: Lumbar Puncture Assisted by LPatPerforming Lumbar Puncture utilizing LPat device | Device | LPat Device |
Primary outcome
Successful Lumbar Puncture
Time frame: Immediate
Obtain CSF
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Meningitis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Fungal Infection Susceptibility
Cryptococcal Infection, Cryptococcal Pneumonia
RecruitingObservational study
Acute Treatment and Long-term Assessment of Adult Infectious Meningitis
Viral Meningitis, Bacterial Meningitis
RecruitingObservational study
Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
Idiopathic CD4+ Lymphocytopenia, Cryptococcal Meningitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningitis and Encephalitis, run by Spartanburg Regional Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Lumbar Puncture (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.