BrightPoint Reflectometer Device Study

August 7, 2023 updated by: University Hospitals Cleveland Medical Center

Human Clinical Trial to Evaluate the BRIGHTPOINT Reflectometer Device as Secondary Confirmation to Loss of Resistance in Lumbar Epidural Placement

Participants are being asked to participate in this study because they are having an epidural placed for labor. This human clinical trial has been designed to evaluate the use of the BrightPoint Reflectometer Device (AKA BrightPoint device) as secondary confirmation of Loss of Residence (LOR) for lumbar epidural placement by an experienced clinician. For this study, participants will be randomized to receive an epidural by an experienced clinician either with or without the use of the BrightPoint device. Epidurals performed as a part of this study will be done in a manner similar to how epidurals are currently performed in the hospital. The epidural space will be entered using usual loss of resistance technique for all patients. If the BrightPoint device is used, it will be as secondary verification of entry into the epidural space.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Any patient undergoing an epidural procedure

Exclusion Criteria:

  • Previous lumbar spine surgery
  • Any known spinal abnormality that would interferre with successfully advancing a needle into the epidural space
  • Any subject that requires an epidural needle longer than 4.0 inches
  • Any procedure requiring use of CSE needles
  • Any contraindication to neuraxial anesthesia
  • No subjects in advanced active labor, e.g., 6-8 cm dilated
  • Tattoo at the site of epidural insertion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BrightPoint Epidural
Subjects will receive an epidural using the BrightPoint device concurrent with usual LOR technique using the same epidural needle, sterile saline, syringe, etc.
Device: BrightPoint
Data from the BrightPoint device during epidural placement will be collected in real time on a tablet with pre-programmed software including tissue color and light reflectance with time stamps of when epidural space is entered as voiced by clinician per LOR.
No Intervention: Normal Epidural
Subjects will have an epidural placed in usual manner with LOR technique using the same epidural needle, sterile saline, syringe etc. but without use of the BrightPoint device.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of times the BrightPoint device was able to measure Loss of Residence (LOR) accurately.
Time Frame: Up to 90 minutes
This is measured as a Yes or No response.
Up to 90 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of times epidural accessed while using BrightPoint device as measured by clinical log
Time Frame: Up to 90 minutes
Up to 90 minutes
Number of times epidural catheter was used during the procedure as measured by clinical log
Time Frame: Up to 20 minutes
Up to 20 minutes
Number of adverse events as measured by clinician log
Time Frame: Up to 90 minutes
Up to 90 minutes
Number of times the BrightPoint device provided real-time secondary confirmation of Loss of Residence (LOR) as measured by clinician log
Time Frame: Up to 90 minutes
Up to 90 minutes
Number of times the BrightPoint device provided beneficial qualitative/quantitative clinical information to help complete the epidural as measured by clinician log.
Time Frame: Up to 90 minutes
Up to 90 minutes
Number of times clinician experienced the haptic feel of entering the ligamentum flavum (LF) as measured by clinician log
Time Frame: Up to 90 minutes
Up to 90 minutes
Number of times clinician experienced LOR after entering the epidural space as measured by clinician log
Time Frame: Up to 90 minutes
Up to 90 minutes
Number of times clinician experienced the haptic sensation of the needle contacting any tissue that was not expected as measured by clinician log
Time Frame: Up to 90 minutes
Up to 90 minutes
Number of times there were issues with catheterization as measured by clinician log
Time Frame: Up to 90 minutes
Up to 90 minutes
Number of times there were issues achieving pain management as measured by clinician log
Time Frame: Up to 4 hours
Up to 4 hours
Number of times the device indicated the needle tip was entering the LF as measured by clinician log
Time Frame: Up to 20 minutes
Up to 20 minutes
Number of times the device showed a significant change of color from the light in LF to the dark in ES as measured by clinician log
Time Frame: Up to 90 minutes
Up to 90 minutes
Number of times the device showed a significant change of reflectance from high in LF to low in ES as measured by clinician log
Time Frame: Up to 90 minutes
Up to 90 minutes
Number of times the LOR and BrightPoint device agreed as measured by clinician log
Time Frame: Up to 90 minutes
Up to 90 minutes
Number of times coring was observed during procedure as measured by clinician log
Time Frame: Up to 90 minutes
Up to 90 minutes
Number of times the BrightPoint interfered with the ability to perform the epidural placement in the usual manner with LOR and haptic feedback as measured by clinician log
Time Frame: Up to 90 minutes
Up to 90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospitals Cleveland Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lumoptik, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lora Levin, MD, University Hospitals Cleveland Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY20220677

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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